NCT03567265

Brief Summary

The study was carried out to determine the prevalence,incidence and factors associated with intra-abdominal hypertension among patients admitted in three intensive care units in Kampala Uganda. It was a multi-center prospective cohort study carried out in three intensive care units where 126 patients that met the eligibility criteria were included in the study,demographics,of these were recorded and intra-abdominal pressure measured using the intra-vesical technique at 0,24,and 72 hours.data entry was done using epi-data version 3.1.Data analysis is on going.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

April 26, 2018

Last Update Submit

June 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intra-abdominal Hypertension

    Intra-abdominal pressure was measured using the intra-vesicular technique.Three measurements were done for each patient at time intervals of 0,24 and 72 hours.This was recorded in a questionnaire, the mean and maximum Intra-abdominal pressure were recorded.Intra-abdominal Hypertension was defined according to the Word Society of Abdominal Compartment Syndrome.

    6 months

Secondary Outcomes (3)

  • To determine 28_ day ICU mortality of patients with intra-abdominal hypertension.

    6 months

  • To determine duration of mechanical ventilation among patients with intra-abdominal hypertension

    6 months

  • To determine the length of ICU stay among patients with intra-abdominal hypertension

    6 months

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study enrolled critically ill patients admitted in three intensive care units in Kampala Uganda

You may qualify if:

  • All patients admitted to the three intensive care units and were catheterized Patients admitted for more than 24 hours were recruited in the study Patients aged one year and above.

You may not qualify if:

  • Patients in which urethral catheterization was not required
  • The patients that were below one year
  • Patients with contraindications to intra-vesical pressure measurement including: pelvic fracture, haematuria, or neurogenic bladder.
  • Pregnant women
  • Patients admitted for less than 24 hours into the ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nansubuga Phiona

Kampala, +256, Uganda

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Phiona Nansubuga, MBCHB

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 25, 2018

Study Start

September 1, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Locations