Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Completed

• Conditions: AKI (Acute Kidney Injury) Due to Trauma
• Interventions: Other: Observational

• Registration Number: NCT04292262
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-05-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-17
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non AKI	Observational	-
AKI	Observational	-

Primary Outcome Measures

Name	Time	Method
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS	7 days

Secondary Outcome Measures

Name	Time	Method
the length of ICU and hospital stay and 28 days mortality in AKI patients.	28 days

Trial Locations

Locations (1)

Hanaa El Gendy; 🇪🇬 Cairo, Ain Shams University Specialized Hospital, Egypt