Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital

November 30, 2018 updated by: Cherdkiat karnjanarachata, Ramathibodi Hospital
To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly.

Study Type

Observational

Enrollment (Anticipated)

303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cherdkiat Karnjanarachata, MD
  • Phone Number: +66-85-5774747
  • Email: chird_na@yahoo.com

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Ramathibodi hospital
        • Contact:
        • Principal Investigator:
          • Cherdkiat Karnjanarachata, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All postoperative adult patients admitted to institutional surgical ICUs.

Description

Inclusion Criteria:

  • Postoperative patient admitted to surgical ICU
  • Age >/= 18
  • Foley's catheter in place

Exclusion Criteria:

  • Patient refusal
  • Underwent neo-bladder procedure
  • Need continuous bladder irrigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical patients
All postoperative patients admitted to surgical ICU with foley catheter in place
Diagnostic test: Intraabdominal pressure monitoring
Classic manometry technique measurement once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
Time Frame: Within 30 days of ICU admission
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
Within 30 days of ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors of intraabdominal hypertension and abdominal compartment syndrome
Time Frame: Within 30 days of ICU admission
Risk factors of intraabdominal hypertension and abdominal compartment syndrome
Within 30 days of ICU admission
Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
Time Frame: Within 30 days of ICU admission
Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
Within 30 days of ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Cherdkiat Karnjanarachata, MD, Faculty of Medicine, Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 10, 2018

Primary Completion (Anticipated)

December 10, 2019

Study Completion (Anticipated)

June 10, 2020

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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