Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

NCT ID: NCT04292262

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-08-30

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.

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AKI

Observational

Intervention Type: OTHER

Observational

Non AKI

Observational

Intervention Type: OTHER

Observational

Interventions

Observational

Observational

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Countries

Egypt

Other Identifiers

FMASU M S 289/2020

Identifier Type: -

Identifier Source: org_study_id