NCT04292262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

February 28, 2020

Last Update Submit

October 17, 2020

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Outcome Measures

Primary Outcomes (1)

  • Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS

    7 days

Secondary Outcomes (1)

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

    28 days

Study Arms (2)

AKI

Other: Observational

Non AKI

Other: Observational

Interventions

ObservationalOTHER

Observational

AKINon AKI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

a prospective observational cohort study.

You may qualify if:

  • Age from 18 to 70 years old males or females
  • Injury Sensitivity Score (ISS \>15 )

You may not qualify if:

  • Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 3, 2020

Study Start

May 1, 2020

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)