CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
LBP +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05229822
NCT05229822N/ACompleted

Prognostic Significance of Bacterial Translocation Markers as Predictors of Infectious and Inflammatory Complications in Acute Mechanical Bowel Obstruction

Karaganda Medical University·observational·Posted Feb 8, 2022·Updated Jan 16, 2025

In Brief

An observational study evaluating LBP, sCD14-ST, and 1 other intervention for Intestinal Obstruction and 4 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed Summary

Despite modern approaches to the diagnosis and treatment of acute bowel obstruction (ABO), postoperative mortality ranges from 5 to 32%, and complications occur up 23% of cases. One of the formidable infectious and inflammatory complications of ABO is sepsis. The main component of the development of sepsis in ABO is bacterial translocation (BT). BT is the migration of intestinal bacteria or their products through the intestinal mucosa into the mesenteric lymph nodes and further into normally sterile tissues and organs. Today there are several methods for detecting BT: 1. direct method - the detection of 16s rRNA (ribosomal ribonucleic acid) in mesenteric lymph nodes (MLN); 2. indirect method - the detection of serum lipopolysaccharide-binding protein (LBP) and presepsin (Soluble CD14 subtype or sCD14-ST). The aim of this study is to determine the diagnostic and prognostic significance of bacterial translocation as a predictor of the complications development in patients with malignant and benign acute bowel obstruction by assessing the relationship of biomarkers in the systemic circulation (LBP, sCD14-ST) with the detection of microorganism genes (16s rRNA) in mesenteric lymph nodes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesKazakhstan

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 8, 2022
Enrollment StartMar 1, 2021
Primary CompletionOct 31, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.4 years ago

Interventions

LBPother

Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.

sCD14-STother

Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.

16s rRNAother

Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.