Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

October 17, 2020 updated by: Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ain Shams University Specialized Hospital
      • Cairo, Ain Shams University Specialized Hospital, Egypt
        • Hanaa El Gendy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

a prospective observational cohort study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI
Other: Observational
Observational
Non AKI
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
the length of ICU and hospital stay and 28 days mortality in AKI patients.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

August 30, 2020

Study Completion (ACTUAL)

August 30, 2020

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (ACTUAL)

March 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 17, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU M S 289/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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