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

NCT06221293 | Active Not Recruiting DMC

• 2 other identifiers: ИРН АР 19677271ИРН AP19677271
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 5

Brief Summary

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. 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. 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. 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. 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.

Conditions

Intraabdominal Hypertension; Multi-Organ Disorder; Translocation Syndrome

Keywords

bacterial translocation; presepsin; intraabdominal hypertension; multi-organ disorder; I-FABP; REG3a; Zonulin

Outcome Measures

Primary Outcomes (1)

• Detection of biomarkers of translocation

  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.

  3-10 days

Secondary Outcomes (1)

• The differences between level of bacterial translocation and level of markers of the intestinal wall damage with intraabdominal hypertension

  3-10 days

Other Outcomes (1)

• Correlation between the level of intraabdominal hypertension and progression of multi-organ dysfunction

  3-10 days

Study Arms (2)

Group 1

the first group consists of patients with increased abdominal pressure, signs of multi-organ failure with a fatal outcome

Diagnostic Test: immunoenzyme analysis

Group 2

the second group consists of patients with increased abdominal pressure, signs of multi-organ failure without death

Diagnostic Test: immunoenzyme analysis

Interventions

immunoenzyme analysis DIAGNOSTIC_TEST

immunoenzyme analysis with EVOLIS system

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years of age with multi-organ dysfunction syndrome and increased intra-abdominal pressure

You may qualify if:

• registered multiple organ dysfunction syndrome of various genesis
• over 18 years of age.

You may not qualify if:

• age under 18
• pregnancy
• HIV infection

Sponsors & Collaborators

• Karaganda Medical University: lead

Study Sites (5)

Karaganda Medical University

Karaganda, 1000000, Kazakhstan

Location

Clinic of the Medical University of Karaganda

Karaganda, 100000, Kazakhstan

Location

Multidisciplinary hospital No. 1

Karaganda, 100000, Kazakhstan

Location

Multidisciplinary Hospital No. 3

Karaganda, 100000, Kazakhstan

Location

Regional Clinic Hospital

Karaganda, 100000, Kazakhstan

Location

Related Publications (4)

• Turgunov Y, Ogizbayeva A, Akhmaltdinova L, Shakeyev K. Lipopolysaccharide-binding protein as a risk factor for development of infectious and inflammatory postsurgical complications in colorectal cancer paients. Contemp Oncol (Pozn). 2021;25(3):198-203. doi: 10.5114/wo.2021.110051. Epub 2021 Oct 14.

  PMID: 34729040 RESULT

• Shakeyev K, Turgunov Y, Ogizbayeva A, Avdiyenko O, Mugazov M, Grigolashvili S, Azizov I. Presepsin (soluble CD14 subtype) as a risk factor for the development of infectious and inflammatory complications in operated colorectal cancer patients. Ann Coloproctol. 2022 Dec;38(6):442-448. doi: 10.3393/ac.2022.00115.0016. Epub 2022 Apr 4.

  PMID: 35368178 RESULT

• Amanova DY, Lavrinenko AV, Kaliyeva DK, Matyushko DN, Ivachyov PA, Turgunov YM. Comparative Evaluation of Translocation of GFP Producing Escherichia coli Strains in Acute Intestinal Obstruction. Bull Exp Biol Med. 2019 Sep;167(5):660-662. doi: 10.1007/s10517-019-04593-y. Epub 2019 Oct 17.

  PMID: 31625067 RESULT

• Ivachyov P, Amanova D, Akhmaltdinova L, Koishibayev Z, Turgunov E. [COMPARISON OF DYNAMICS OF LEVEL OF PROCALCITONIN, LIPOPOLYSACCHARIDE BINDING PROTEIN AND INTERLEUKIN-6 IN BLOOD SERUM OF EXPERIMENTAL ANIMALS AT STRANGULATED AND OBTURATIVE INTESTINAL OBSTRUCTION]. Georgian Med News. 2020 Jun;(303):173-177. Russian.

  PMID: 32841201 RESULT

Related Links

• Annals of Coloproctology 2022;38(6):442-448
• J CLIN MED KAZ, Volume 18, Issue 3, pp. 8-13.
• J CLIN MED KAZ, Volume 19, Issue 2, pp. 38-42.

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alina Ogizbaeva, dr

  young scientist, phD

  PRINCIPAL INVESTIGATOR

• Kairat Shakeyev, dr

  head of the surgical service of the CSE "Multidisciplinary Hospital No. 3 of Karaganda

  PRINCIPAL INVESTIGATOR

• Dmitry Matyushko, dr

  PhD, Associate Professor of the Department of Surgical Diseases

  PRINCIPAL INVESTIGATOR

• Miras Mugazov, dr

  PhD, Associate Professor of the Department of Emergency Medical Care

  PRINCIPAL INVESTIGATOR

• Dana Amanova, dr

  PhD, young scientist, co-investigator

  STUDY CHAIR

• Zhibek Zhumadilova

  young scientist, co-investigator

  STUDY CHAIR

• Shynggys Nuraly

  young scientist, co-investigator

  STUDY CHAIR

• Sofiko Assamidanova

  young scientist, co-investigator

  STUDY CHAIR

• Yermek Turgunov, dr

  professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: March 1, 2023
• Primary Completion: December 25, 2025
• Study Completion: December 27, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (5)