Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04292262

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AKI (Acute Kidney Injury) Due to Trauma	Other: Observational

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
AKI	Other: Observational Observational
Non AKI	Other: Observational Observational

Arm

Intervention/Treatment

AKI

Other: Observational

Observational

Non AKI

Other: Observational

Observational

Outcome Measures

Primary Outcome Measures

Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS [7 days]

Secondary Outcome Measures

the length of ICU and hospital stay and 28 days mortality in AKI patients. [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanaa El Gendy	Cairo	Ain Shams University Specialized Hospital	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanaa Mohamed Abdallah ElGendy MD, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04292262

Other Study ID Numbers:

FMASU M S 289/2020

First Posted:

Mar 3, 2020

Last Update Posted:

Oct 20, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Multiple Trauma

Study Results

No Results Posted as of Oct 20, 2020