Clinical trial NCT03670771: Intraabdominal Pressure in Critically Ill Patients
Official title: Incidence and Prognostic Significance of Intraabdominal Pressure in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Intra-Abdominal Hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: evaluate the incidence and prognostic significance of IAH in medical ICU patients.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ruiz Ferron F, Tejero Pedregosa A, Ruiz Garcia M, Ferrezuelo Mata A, Perez Valenzuela J, Quiros Barrera R, Rucabado Aguilar L. [Intraabdominal and thoracic pressure in critically ill patients with suspected intraabdominal hypertension]. Med Intensiva. 2011 Jun-Jul;35(5):274-9. doi: 10.1016/j.medin.2011.02.009. Epub 2011 Apr 15. Spanish.