Intraabdominal Pressure in Critically Ill Patients

September 15, 2018 updated by: Nehal sayed ahmed, Assiut University

Incidence and Prognostic Significance of Intraabdominal Pressure in Critically Ill Patients

This study is conducted to evaluate the incidence and prognostic significance of IAH in medical ICU patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Increased Intra-abdominal pressure (IAP) is an important cause of morbidity and mortality in ICU patients with consequent pulmonary, hepatic, central nervous and renal system impairments.

The increase in IAP is rarely diagnosed in ICU and the lack of diagnosis of this condition may lead to the worsening of patient prognoses because of retardation of appropriate interventions .

The current literatures show conflicting cutoff values of IAP that predict AKI, possibly due to the fact that many studies were conducted before publishing of the first Consensus of IAH/ACS, which standardized the measurement method of IAP.

Intra-abdominal hypertension is defined as a sustained or repeated pathologic elevation of intra-abdominal pressure greater than 12 mmHg [Malbrain et al 2004, cheathamML et al 2007]. Intra-abdominal hypertension is graded as follows:

  • Grade I Intra-abdominal pressure 12-15 mmHg.
  • Grade II Intra-abdominal pressure 16-20 mmHg.
  • Grade III Intra-abdominal pressure 21-25 mmHg.
  • Grade IV Intra-abdominal pressure greater than 25 mmHg Various risk factors contribute to the development of IAH in medical ICU including; massive fluid resuscitation (> 3500 ml/24 h), ileus, respiratory, renal, or liver dysfunction, hypothermia, acidosis, anemia, oliguria, and hyperlactatemia .

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients admitted to ICU due to medical cause irrespective of age or sex will be included in the study with detailed history and compelete examination will be done ,ECG will be done

, SPO2 and arterial lactate concentrations and blood gases will be recorded twice daily, intraabdominal pressure wil be measured every at ltime of admission and every 6 hours until discharge or death occured.

Description

Inclusion Criteria:

• All patients admitted to the critical care unit of internal medicine department not listed in the exclusion criteria.

Exclusion Criteria:

  • Patients diagnosed with ESRD on dialysis.
  • Patients with contraindications for internal urethral catheterization as urethral injury.
  • Patients who had an obvious increase in IAP as; pregnant women and obese with body mass index (BMI) > 32 kg/m2.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the incidence and prognostic significance of IAH in medical ICU patients.
Time Frame: one year
occurance of death ,improvement or organ failure
one year

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 15, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • critically ill patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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