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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03670771
Other study ID # critically ill patients
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date December 30, 2020

Study information

Verified date September 2018
Source Assiut University
Contact nehal s. ahmed, specialist
Phone 00201094627608
Email nehalsayed181087@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 30, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Harrahill method for measuring of intraabdominal pressure
IAP obtained by using patient own urine as the transducing medium. One clamps the Foley catheter just above the urine collection bag. The tubing is then held at a position of 30-40 cm above the symphysis pubis and the clamp is released. The IAP is indicated by the height (in cm) of the urine column from the pubic bone. The meniscus should show respiratory variations.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Ruiz Ferrón F, Tejero Pedregosa A, Ruiz García M, Ferrezuelo Mata A, Pérez Valenzuela J, Quirós Barrera R, Rucabado Aguilar L. [Intraabdominal and thoracic pressure in critically ill patients with suspected intraabdominal hypertension]. Med Intensiva. 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate the incidence and prognostic significance of IAH in medical ICU patients. occurance of death ,improvement or organ failure one year
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