Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

AKI (Acute Kidney Injury) Due to Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292262
• Other study ID #: FMASU M S 289/2020
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• AKI (Acute Kidney Injury) Due to Trauma
• Multiple Trauma
• Wounds and Injuries

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Egypt	Hanaa El Gendy	Cairo	Ain Shams University Specialized Hospital

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS		7 days
Secondary	the length of ICU and hospital stay and 28 days mortality in AKI patients.		28 days