NCT03670771

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 12, 2018

Last Update Submit

September 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluate the incidence and prognostic significance of IAH in medical ICU patients.

    occurance of death ,improvement or organ failure

    one year

Interventions

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Critical IllnessIntra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCompartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

nehal s. ahmed, specialist

CONTACT

ahmed b. ahmed, lecturer

CONTACT

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

September 12, 2018

First Posted

September 14, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2020

Study Completion

December 30, 2020

Last Updated

September 18, 2018

Record last verified: 2018-09