Evaluation of Procalcitonin Versus Conventional Inflammatory Biomarkers for Clinical Severity Grading in Patients with Intra-Abdominal Infection

doi:10.21203/rs.3.rs-5031772/v1

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Research Article

Evaluation of Procalcitonin Versus Conventional Inflammatory Biomarkers for Clinical Severity Grading in Patients with Intra-Abdominal Infection

https://doi.org/10.21203/rs.3.rs-5031772/v1

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Aim

We aimed to evaluate the properties of procalcitonin (PCT) as a biomarker for clinical severity grading of intra-abdominal infections (IAI) in hospital-admitted patients presenting with acute abdomen.

Methods

In this retrospective study, median PCT values were compared with conventional inflammatory biomarkers, including leukocyte count (LC), neutrophil count (NC), and C-reactive protein (CRP), within the patient population.

Results

Among the 245 patients included in the study, 58 (23.7%) were diagnosed with appendicitis, 54 (22.0%) with diverticulitis, 34 (13.9%) with calculous cholecystitis, and 21 (8.6%) with pancreatitis. Additionally, 60 (24.5%) were diagnosed with non-specific abdominal pain (NSAP), and 18 (7.3%) with gallstones without cholecystitis. Median PCT levels were significantly higher in patients with calculous cholecystitis (p < 0.0001) and pancreatitis (p < 0.0001) compared to those with NSAP. The proportion of patients with a PCT cut-off ≥ 0.04 µg/L was significantly higher across all IAI subgroups compared to the NSAP group. However, 18 (10.8%) of IAI patients exhibited PCT levels ≥ 0.5 µg/L, indicating systemic infection. Spearman’s rho analysis revealed a significant correlation between PCT and LC, NC, and CRP in patients with IAI (p < 0.0001). Moreover, median PCT levels were significantly higher in perforation/abscess vs. gangrenous appendicitis (p < 0.01), complicated vs. uncomplicated diverticulitis (p = 0.048), and severe vs. mild cholecystitis (p < 0.001).

Conclusion

PCT correlates strongly with conventional inflammatory biomarkers in patients with IAI. However, PCT appears to offer limited additional clinical value for guiding therapeutic decisions concerning the initial diagnosis and/or severity grading of IAI in patients admitted with acute abdomen. Further research is warranted to validate these findings.

Procalcitonin

intra-abdominal infection

inflammatory biomarkers

Intra-abdominal infection (IAI) is a common cause of acute abdomen, often necessitating prompt clinical evaluation. In severe cases, antibiotic therapy may be required to prevent complications such as peritonitis and septicemia^1,2. IAI encompasses several common surgical emergency diagnoses, including appendicitis, cholecystitis, and diverticulitis. Specific antibiotic guidelines exist for various IAI diagnoses, with clinical severity grading being crucial for determining the appropriate antibiotic treatment. However, not all IAI cases, such as uncomplicated diverticulitis³ and mild pancreatitis⁴, require antibiotics.

Conventional inflammatory biomarkers, including leukocyte count (LC), neutrophil count (NC), and C-reactive protein (CRP) ⁵, are routinely utilized to assist in diagnosing patients with suspected IAI and acute abdomen⁶. Elevated levels of these biomarkers often indicate bacterial infections that may necessitate antibiotic therapy⁷. However, the effectiveness of these conventional inflammatory biomarkers in guiding antibiotic treatment decisions warrants further investigation⁸. While these biomarkers remain valuable in acute settings, they lack diagnostic accuracy for complicated appendicitis^9,10.

In recent years, plasma procalcitonin (PCT) has gained increasing attention as a laboratory test for detecting and monitoring bacterial infections of various origins^11,12. Although PCT levels are typically very low (< 0.1 ng/mL) in healthy individuals, they rise in response to bacterial infections, making PCT a more specific inflammatory marker of bacterial disease compared to CRP¹³. The standard PCT cut-off value for bacterial infection is 0.5 ng/mL (µg/L), with a reported sensitivity of 76% and specificity of 69%¹⁴. Although PCT has been reported to correlate with the clinical severity of appendicitis^15–18, cholecystitis^19,20, diverticulitis²¹, and pancreatitis^22,23, its effectiveness as a biomarker for diagnosing IAI in patients with acute abdomen, compared to conventional inflammatory biomarkers, remains unclear^24–26.

This study aimed to evaluate procalcitonin (PCT) in comparison with conventional inflammatory biomarkers (LC, NC, and CRP) for severity grading of intra-abdominal infection (IAI) diagnoses among patients admitted to the surgical emergency department with acute abdomen.

Data Sources

Demographic and clinical data were retrieved from the patients' digital medical records, including age, gender, biochemistry with a focus on conventional inflammatory biomarkers and PCT, radiological/histopathological findings, and diagnoses based on the International Classification of Diseases, 10th Revision (ICD-10) ²⁷. The REDCap data management system was utilized for the collection and management of the study data²⁸.

Study population

This single-center retrospective study was conducted at the North Denmark Regional Hospital. The study population consisted of adult patients (age ≥ 18 years) with acute abdomen admitted to the surgical emergency department during a four-month period between 01/05/2018 and 31/08/2018. Patients who received antibiotics within the previous 4 weeks prior to admission were excluded. The population was divided according to the final diagnosis, either non-specific abdominal pain (NSAP) or one of the following four IAI diagnoses (i.e., acute appendicitis, diverticulitis, calculous cholecystitis, or pancreatitis).

Clinical Severity Grading of IAI

Each of the four specific IAI diagnoses was subcategorized by clinical severity according to radiological and histopathological findings: acute appendicitis (phlegmonous, gangrenous, or perforation/abscess) ¹⁶, calculous cholecystitis (mild or severe) ²⁹, diverticulitis (uncomplicated or complicated—classified according to Hinchey 1–2 and 3–4 classifications) ³⁰, and pancreatitis (mild or severe—classified according to the Glasgow-Imrie Criteria) ³¹. It is important to note that patients with a final diagnosis of gallstones without cholecystitis were not considered as having an IAI diagnosis.

Inflammatory Biomarkers

Blood samples for routine biochemical and hematological analyses, including conventional inflammatory biomarkers (LC, NC, and CRP), were obtained from patients within 2 hours of admission to the surgical emergency department. The results of the laboratory analyses were available for clinical evaluation within one hour. In contrast, PCT was measured in a batch of pooled plasma samples after the study inclusion period ended, ensuring that the attending clinicians were blinded to the PCT results upon admission. The laboratory reference values for the three conventional inflammatory biomarkers were as follows: LC (≥ 10.0 x 10⁹/L), NC (≥ 7.00 x 10⁹/L), and CRP (≥ 8.0 mg/L). A laboratory cut-off value of ≥ 0.04 µg/L was used in this study, in accordance with local standard operating procedures at the Department of Medical Biochemistry, North Denmark Regional Hospital. A PCT cut-off value of ≥ 0.5 µg/L^32,33 is typically considered indicative of systemic infection.

Statistical Methods

Nominal and ordinal parameters were described as percentages using frequency analysis. Fisher's exact test was employed to assess differences between categorical variables. Continuous variables were examined for distribution patterns and were all found to be non-parametric; therefore, they are described using median values with interquartile ranges (IQR), including the 25th and 75th percentiles. The conventional inflammatory biomarkers and PCT were analyzed within the IAI diagnoses and compared to the values obtained from patients diagnosed with NSAP. The two-sample Wilcoxon rank-sum test (Mann-Whitney U test) was used to assess the equality of medians, while the Kruskal-Wallis test was utilized to evaluate the equality of medians across three or more subgroups. Spearman's rho correlation analysis was conducted to analyze the correlation between conventional inflammatory biomarkers and PCT among patients with IAI diagnoses, with log-transformed values of CRP and PCT presented for better illustration of distribution patterns. Statistical analyses were performed using Stata version 17.

Ethical Considerations and Project Registration

Approval from the North Denmark Regional Committee for Health Research Ethics was not deemed necessary, as this was a clinical quality assurance study. The study was registered in the Clinical Research Registry of the North Denmark Region.

A total of 245 patients admitted with a surgical emergency were included in the overall study (Table 1). The median age (IQR) was 53 (38–67) years, and 146 (59.6%) were female. A subtotal of 167 patients (68.2%) met one of the four pre-selected IAI diagnoses: acute appendicitis (n = 58, 23.7%), calculous cholecystitis (n = 34, 13.9%), diverticulitis (n = 54, 22.0%), and pancreatitis (n = 21, 8.6%). Additionally, 60 (24.5%) patients were diagnosed with non-specific abdominal pain (NSAP), and 18 (7.3%) patients with gallstones without cholecystitis.

Table 1

Demographic and clinical characteristics of the study population
	N = 245
Age, years, median (IQR)	53 (38–67)
Gender, n (%)
Females	146 (59.6)
Males	99 (40.4)
Diagnoses, n (%)
Acute appendicitis	58 (23.7)
Phlegmonous	19 (7.8)
Gangrenous	23 (9.4)
Perforation/abscess	16 (6.5)
Diverticulitis	54 (22.0)
Uncomplicated	37 (15.1)
Complicated	17 (6.9)
Gallstone ± cholecystitis	52 (21.2)
Gallstones without cholecystitis	18 (7.3)
Mild calculous cholecystitis	20 (8.2)
Severe calculous cholecystitis	14 (5.7)
Pancreatitis	21 (8.6)
Mild	18 (7.4)
Severe	3 (1.2)
Non-specific abdominal pain	60 (24.5)
IQR:25th – 75th Interquartile range.

Comparison of PCT and Conventional Inflammatory Biomarkers

Table 2 presents the median values (IQR) of the conventional inflammatory biomarkers (LC, NC, CRP) and PCT, comparing the NSAP group with the four IAI subgroups. Additionally, it compares the number (%) of patients with PCT cut-off values ≥ 0.04 µg/L and ≥ 0.5 µg/L, respectively. We found that all IAI diagnoses exhibited significantly increased values of the conventional inflammatory biomarkers compared to the NSAP group. The median PCT values were significantly higher in patients with cholecystitis and pancreatitis compared to those with NSAP. While the median PCT was comparable to that of NSAP for acute appendicitis and diverticulitis, the proportions of patients with PCT cut-off values ≥ 0.04 µg/L were significantly higher in all four IAI subgroups compared to NSAP. A similar trend was observed for PCT cut-off values ≥ 0.5 µg/L, except in patients with diverticulitis, where too few patients in all IAI diagnoses exhibited PCT cut-off values ≥ 0.5 µg/L.

Table 2

Inflammatory biomarkers findings in patients with non-specific abdominal pain versus patients with appendix, diverticulitis, calculous cholecystitis, and pancreatitis, respectively.
		Median values (IQR)				n (%)
		Leukocyte count	Neutrophile count	C-reactive protein	Procalcitonin	Procalcitonin*
	n	10⁹/L	10⁹/L	mg/L	µg/L	≥ 0.04 µg/L	≥ 0.5 µg/L
Non-specific abdominal pain	60	9.1 (7.3–11.1)	6.2 (4.7–7.7)	5.5 (2.9–15.5)	0.05 (0.05–0.07)	17 (28.3)	0 (0)
versus
Acute appendicitis	58	13.2 (10.5–17.5)	11.3 (7.8–14.5)	37.5 (9.9–77.0)	0.06 (0.04–0.12)	27 (46,6)	5 (8.6)
p-value		< 0.0001	< 0.0001	< 0.0001	0.06	< 0.01	< 0.01
Diverticulitis	54	11.4 (9.3–13.3)	8.6 (6.5–10.3)	82.2 (48.0–121.0)	0.05 (0.04–0.1)	22 (40.7)	1 (1.9)
p-value		0.0001	< 0.0001	< 0.0001	0.12	0.02	0.23
Calculous cholecystitis †	34	13.4 (10.6–17.2)	10.4 (8.1– 14.5)	81.5 (13.0–177.0)	0.27 (0.05–0.5)	22 (64.7)	6 (17.6)
p-value		< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001
Pancreatitis	21	12.3 (10.1–14.7)	9.3 (7.3–12.7)	74.6 (7.8–94)	0.24 (0.07–0.71)	13 (61.9)	6 (28.6)
p-value		< 0.0001	< 0.0001	< 0.001	< 0.0001	< 0.001	< 0.0001
IQR: 25th – 75th Interquartile range.
Two-sample Wilcoxon rank-sum (Mann-Whitney) test was applied to assess the equality of medians comparing NSAP with IAI diagnoses.
* Fisher´s exact test was used to assess the differences for the categorical variables.
† Calculous cholecystitis excluding gallstones without cholecystitis.

Figure 1 depicts the Spearman’s rho correlation analyses among conventional inflammatory biomarkers and PCT in patients with IAI diagnoses. All conventional inflammatory biomarkers and PCT exhibited significant correlations in IAI patients; LC vs. CRP (p < 0.0001), LC vs. PCT (p < 0.0001), NC vs. PCT (p < 0.0001), and CRP vs. PCT (p < 0.0001), respectively.

Biomarkers in Clinical Severity Grading Context

Figure 2 illustrates the comparative representation of the conventional inflammatory biomarkers and PCT according to the severity of appendicitis, diverticulitis, and cholecystitis. More severe cases of appendicitis exhibited significantly and consistently higher LC and NC median values. Although we observed significantly different medians of CRP (p = 0.026) and PCT (p = 0.01) among appendicitis subgroups, CRP and PCT medians showed no significant difference between phlegmonous and gangrenous appendicitis. However, both CRP (p = 0.045) and PCT (p = 0.005) medians were significantly higher in perforation/abscess compared to gangrenous appendicitis.

Complicated diverticulitis cases, compared to uncomplicated cases, demonstrated significantly and consistently higher LC (p = 0.007), NC (p = 0.01), and PCT (p = 0.048) median values, while CRP medians did not differ significantly (p = 0.199) between complicated and uncomplicated cases.

More severe cases of cholecystitis (gallstones without cholecystitis vs. mild vs. severe) exhibited significantly and consistently higher LC, NC, and CRP median values. Although the PCT median and distribution were visibly higher on a log-scale when comparing mild cholecystitis vs. gallstones without cholecystitis, the difference in medians was not significant (p = 0.065). In contrast, significantly higher PCT medians and distributions were found when comparing severe vs. mild cases (p = 0.0003). Notably, patients with pancreatitis (n = 21) were divided into mild (n = 18) and severe (n = 3) groups, and, as expected, inflammatory biomarker levels did not show significant differences in the severity grading of pancreatitis (p = 0.40).

This study explored the properties of PCT in grading IAI clinical severity compared with a panel of conventional inflammatory biomarkers. From an IAI diagnosis-specific perspective, median PCT values were significantly higher in patients with cholecystitis and pancreatitis, but not in those with appendicitis and diverticulitis, compared with NSAP. The proportions of patients with PCT cut-off values ≥ 0.04 µg/L were significantly higher in all four IAI subgroups compared with NSAP. However, a surprisingly low proportion of patients with IAI exhibited PCT cut-off values ≥ 0.5 µg/L. A strong correlation exists among conventional inflammatory biomarkers and PCT in patients with IAI. In terms of severity grading, the median PCT values were significantly higher only in perforation/abscess vs. gangrenous appendicitis, complicated vs. uncomplicated diverticulitis, and severe vs. mild cholecystitis.

The results of this study provide valuable insights into the role of PCT and conventional inflammatory biomarkers in the diagnosis and severity assessment of IAIs. Our findings show that median PCT values were significantly higher in patients with calculous cholecystitis and pancreatitis compared to those with NSAP, but not in appendicitis and diverticulitis compared with NSAP. Additionally, a higher proportion of patients in all four IAI subgroups had PCT levels ≥ 0.04 µg/L compared with the NSAP group. Similarly, PCT levels ≥ 0.5 µg/L, considered the standard for bacterial infection, were statistically significantly higher, except in patients with diverticulitis. It is noteworthy that a low proportion of patients with IAI exhibited PCT values ≥ 0.5 µg/L, despite this cut-off being the accepted standard for bacterial infections. Importantly, PCT demonstrated a strong correlation with other established markers of inflammation, including LC, NC, and CRP.

Conventional biomarkers such as LC and NC significantly increase with the severity of acute appendicitis, diverticulitis, and cholecystitis, except pancreatitis, whereas CRP did not significantly increase in complicated diverticulitis or pancreatitis. Regarding severity grading, median PCT values were significantly higher only in perforation/abscess vs. gangrenous appendicitis, complicated vs. uncomplicated diverticulitis, and severe vs. mild cholecystitis, suggesting its potential utility as a severity indicator, except in pancreatitis severity grading. These findings support the potential of PCT as a valuable biomarker in assessing the severity of IAI, which could have important implications for decision-making.

In a systematic review by Joseph et al., PCT is highlighted as valuable for assessing appendicitis severity, especially in cases with perforation, gangrene, or necrosis¹⁷. Similarly, López et al. observed higher PCT levels in patients with complicated appendicitis³⁴. Our study also found a significant difference in PCT levels, supporting its potential as a diagnostic tool for assessing the severity of acute appendicitis and guiding early antibiotic treatment (p = 0.01).

Victor et al. noted that combining PCT with abdominal CT scans could reduce antibiotic use by 80%, aiding clinical decision-making²¹. In our study, antibiotic treatment was not initiated in uncomplicated diverticulitis patients after diagnosis by CT scan, except in certain cases. Therefore, in our context, PCT evaluation should be aligned with CT scans for patients presenting to the emergency department to help determine whether to initiate antibiotics, rather than considering discontinuation once antibiotics have been started. Julide et al. reported higher PCT levels in more severe diverticulitis cases (Hinchey stages 3–4) ³⁵. Both Victor et al. and Julide et al. found that median PCT levels are useful in differentiating complicated from uncomplicated diverticulitis. Consistent with these findings, our study confirmed the statistical significance of PCT in differentiating between uncomplicated and complicated diverticulitis. However, PCT did not prove to be superior to already established biomarkers such as LC and NC.

PCT is reported as a useful laboratory tool, similar to other biomarkers, in assessing the severity of acute cholecystitis²⁰. In this study, a statistically significant increase in disease severity was detected with rising PCT levels in 95 patients with calculous cholecystitis. Wu et al. further supported PCT’s role by indicating that its elevation could serve as a preoperative risk assessment tool in acute cholecystitis patients³⁶. In contrast, Yucel et al. found that PCT alone is not effective but could be considered an additional biomarker in the “Tokyo Guidelines²⁹” for assessing the severity of acute cholecystitis³⁷. In our study, PCT levels correlated with the severity of acute calculous cholecystitis. However, while differentiating between mild and severe forms of cholecystitis, our results suggest that PCT may not add significant value in determining the urgency and aggressiveness of antibiotic treatment or the timing of surgery.

PCT-guided care can reduce antibiotic use in acute pancreatitis without harm, according to Siriwardena et al.³⁸, and the reliability of PCT in assessing severity and predicting antibiotic requirements was validated by Alberti et al.³⁹ Additionally, Mann et al. suggested a role for PCT in antibiotic initiation, duration, risk of organ failure, and mortality prediction⁴⁰. Conversely, Tarjan et al. found that the predictive value of PCT for early infections was limited but improved over time, especially in necrotizing pancreatitis⁴¹. In this meta-analysis, which included 13 studies, the severity of acute pancreatitis was evaluated through repeated PCT measurements after 48 hours. However, in our study involving 21 pancreatitis patients, severity was assessed with a single measurement correlated with CT scan findings, indicating the need for repeated PCT measurements in future studies. In contrast, in our study, PCT was not significant for assessing severity or guiding early antibiotic use in pancreatitis.

The main limitation of our data pertains to its retrospective observational nature, with potential confounders. Firstly, this was a single-center quality control study aimed at reporting our findings, making the results specific to our practice and influenced by population characteristics. Furthermore, the smaller number of patients in the subgroups introduces the potential for type 1 error. Additionally, the absence of data on other clinical parameters (e.g., temperature, vital signs) and comorbidities limits a comprehensive understanding.

Despite these inherent limitations, our retrospective single-center study provides valuable insights based on a robust real-world experience involving a regional cohort of unselected acute abdomen patients with precise bio-clinical data. We employed well-established methodologies, enhancing the reliability of our findings. To strengthen the validity of our results, we exclusively examined primary final diagnoses, ensuring that hospital admissions were directly attributable to our specified endpoints rather than being influenced by prior registry records or secondary complications. Notably, the inclusive nature of our data, encompassing all residents of the region regardless of labor market participation, minimizes selection bias related to specific age groups or insurance systems, thereby bolstering the generalizability of our results.

In conclusion, the study demonstrated that PCT is strongly correlated with conventional inflammatory biomarkers in patients with IAI. However, PCT appears to provide limited additional clinical value in guiding therapy decisions regarding the initial diagnosis and/or severity grading of IAI for patients admitted with acute abdomen in emergency settings. Further research with larger and more diverse patient populations is warranted to validate our observations and better understand the real value and clinical utility of PCT in managing acute abdomen.

Conflict of Interest

None.

Funding

None.

Author Contribution

C.O., and P.D.C.L. was responsible for collecting data, ensuring coordination, obtaining necessary approvals and planning.C.O., A.Y, D.K.,P.D.C.L., and K.H wrote the main manuscript text. C.O., P.D.C.L., D.K., and K.H. prepared figures and tables. D.K., and K.H. made statistical analysis.S.H.P. prepared the pathology results.P.H. prepared biochemistry results.P.D.C.L., D.K., and K.H. reviewed the manuscript

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Evaluation of Procalcitonin Versus Conventional Inflammatory Biomarkers for Clinical Severity Grading in Patients with Intra-Abdominal Infection

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Version 1

Abstract

Aim

Methods

Results

Conclusion

Figures

INTRODUCTION

MATERIALS AND METHODS

Data Sources

Study population

Clinical Severity Grading of IAI

Inflammatory Biomarkers

Statistical Methods

Ethical Considerations and Project Registration

RESULTS

Comparison of PCT and Conventional Inflammatory Biomarkers

Biomarkers in Clinical Severity Grading Context

DISCUSSION

Declarations

Conflict of Interest

Funding

Author Contribution

References

Additional Declarations

Status:

Version 1