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Clinical Trials/NCT04292262
NCT04292262
Completed
Not Applicable

A Prospective Observational Study on the Incidence of Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Ain Shams University1 site in 1 country60 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
AKI (Acute Kidney Injury) Due to Trauma
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Acute Kidney Injury (AKI) is a common complication of severe trauma patients and is associated with increased morbidity and mortality.Trauma patients have many risk factors for AKI such as hypovolemic shock, rhabdomyolysis, massive transfusion, major surgeries and abdominal compartment syndrome.The primary outcome of the study is to correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS .The secondary outcomes are ;the length of ICU and hospital stay and 28 days mortality in AKI patients.

Detailed Description

• Study Population: 60 cases of polytrauma patients who have ISS\>15. * Inclusion Criteria: * Age from 18 to 70 years old males or females * Injury Sensitivity Score (ISS \>15 ) * Exclusion Criteria: Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure. Sample size :the calculated sample size is 60 cases of trauma patients. • All patients' data will be recorded on admission and daily for 7 days: * Vital signs (blood pressure, heart rate, respiratory rate, body temperature). * Lab investigations: complete blood count, international normalized ratio, prothrombin time, arterial blood gases, kidney function tests, liver function tests, creatine kinase, creatine kinase-muscle band, creatinine clearance, serum sodium, serum potassium and serum phosphorus will be requested for all patients at admission then daily follow up by creatine kinase, creatine kinase-muscle band, kidney function tests, serum sodium, serum potassium and serum phosphorus for 7 days. Glasgow Coma Scale (GCS), Injury Severity Score (ISS),Urine output (ml/kg/h),RIFLE criteria.,Length of ICU and hospital stay,28 days mortality.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • • Age from 18 to 70 years old males or females
  • Injury Sensitivity Score (ISS \>15 )

Exclusion Criteria

  • Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Outcomes

Primary Outcomes

Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS

Time Frame: 7 days

Secondary Outcomes

  • the length of ICU and hospital stay and 28 days mortality in AKI patients.(28 days)

Study Sites (1)

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