Intraabdominal Pressure in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Incidence and Prognostic Significance of Intraabdominal Pressure in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03670771
• Other study ID #: critically ill patients
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Critical Illness
• Intra-Abdominal Hypertension

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