NCT03762057

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 30, 2018

Last Update Submit

November 30, 2018

Conditions

Intraabdominal HypertensionAbdominal Compartment Syndrome

Keywords

Intraabdominal HypertensionAbdominal Compartment SyndromePrevalenceRisk factorsICUSurgical

Outcome Measures

Primary Outcomes (1)

  • Prevalence of intraabdominal hypertension and abdominal compartment syndrome

    Prevalence of intraabdominal hypertension and abdominal compartment syndrome

    Within 30 days of ICU admission

Secondary Outcomes (2)

  • 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

    Within 30 days of ICU admission

Study Arms (1)

Surgical patients

All postoperative patients admitted to surgical ICU with foley catheter in place

Diagnostic Test: Intraabdominal pressure monitoring

Interventions

Intraabdominal pressure monitoringDIAGNOSTIC_TEST

Classic manometry technique measurement once daily

Surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All postoperative adult patients admitted to institutional surgical ICUs.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cherdkiat Karnjanarachata, MD

    Faculty of medicine, Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherdkiat Karnjanarachata, MD

CONTACT

+66-85-5774747chird_na@yahoo.com

Kittikhun Narkasawet, MD

CONTACT

+66-81-6820808konkengsood@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

December 10, 2018

Primary Completion

December 10, 2019

Study Completion

June 10, 2020

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)