NCT06221293

Correlation Between Intra-abdominal Pressure, Biomarkers of Bacterial Translocation and Intestinal Wall Damage

Active, enrolled Last updated 19 April 2024

What this trial tests

trial testing immunoenzyme analysis in Intraabdominal Hypertension in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2023

Primary endpoint
25 December 2025

27 December 2025

Quick facts

Lead sponsor	Karaganda Medical University
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	180
Start date	1 March 2023
Primary completion	25 December 2025
Estimated completion	27 December 2025
Sites	5 locations across Kazakhstan

Drugs / interventions tested

• immunoenzyme analysis

Conditions studied

• Intraabdominal Hypertension — all drugs for Intraabdominal Hypertension →
• Multi-Organ Disorder — all drugs for Multi-Organ Disorder →
• Translocation Syndrome — all drugs for Translocation Syndrome →

Sponsor

Karaganda Medical University

Who can join

Adults 18 to 90, any sex, with Intraabdominal Hypertension or Multi-Organ Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Main scientific hypotheses of the project:

1\. The level of intestinal microflora translocation markers and biomarkers of intestinal wall damage the in the blood serum correlates with the level of intra-abdominal pressure, regardless of the genesis of intra-abdominal hypertension.

2\. The critical levels of intestinal microflora translocation markers and biomarkers of the intestinal wall damage can be used for predicting an unfavorable outcome in the multiple organ dysfunction syndrome.

3\. The revealed critical level of intra-abdominal pressure is an additional prognostic sign in assessing the course of the multiple organ dysfunction syndrome.

. Project objectives:

1. To evaluate the indicators of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage in the systemic circulation during the development and course of the syndrome of multiple organ dysfunction. Based on the obtained critical levels of markers of translocation of the intestinal microflora and markers of the intestinal wall damage, it will be possible to predict adverse outcomes in patients with multiple organ dysfunction syndrome.
2. To identify differences in the level of markers of bacterial translocation of the intestinal microflora and the level of markers of the intestinal wall damage in patients with intra-abdominal hypertension. In patients with multiple organ dysfunction syndrome, the levels of biomarkers of bacterial translocation of the intestinal microflora and biomarkers of intestinal wall damage in the blood serum correlate with intra-abdominal pressure indicators, regardless of the etiology of intra-abdominal hypertension.
3. Assess the impact of the level of intra-abdominal pressure on the development and course of the syndrome of multiple organ dysfunction. To assess the course of the syndrome of multiple organ dysfunction, an additional prognostic marker is the determination of the critical level of intra-abdominal pressure.
4. Determine the critical levels of biomarkers of intestinal microflora translocation and biomarkers of intestinal wall damage to predict the outcome of diseases accompanied by the development of multiple organ dysfunction syndrome. The obtained critical levels of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage will be significant indicators in the syndrome of multiple organ dysfunction for predicting an unfavorable outcome.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of I-FABP, REG3α, sCD14-ST, and LBP as Indicators of GI Tract Injury in MODS Patients.
   Turgunov Y, Ogizbayeva A, Assamidanova S, Matyushko D, et al · · 2025 · PMID 40075763 · DOI 10.3390/diagnostics15050515