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NCT03762057 Clinical Trial

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

Abdominal Compartment Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03762057
Other study ID # CK999
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 10, 2018
Est. completion date June 10, 2020

Study information
Verified date November 2018
Source Ramathibodi Hospital
Contact Cherdkiat Karnjanarachata, MD
Phone +66-85-5774747
Email chird_na@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 303
Est. completion date June 10, 2020
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intraabdominal pressure monitoring
Classic manometry technique measurement once daily

Locations
Country Name City State
Thailand Ramathibodi Hospital Ratchathewi Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of intraabdominal hypertension and abdominal compartment syndrome Prevalence of intraabdominal hypertension and abdominal compartment syndrome Within 30 days of ICU admission
Secondary Risk factors of intraabdominal hypertension and abdominal compartment syndrome Risk factors of intraabdominal hypertension and abdominal compartment syndrome Within 30 days of ICU admission
Secondary Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome Within 30 days of ICU admission
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