NCT06051708

Brief Summary

The aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

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

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

September 17, 2023

Last Update Submit

June 15, 2024

Conditions

Keywords

AKIHospital Acquiredrisk factorsoutcomes

Outcome Measures

Primary Outcomes (1)

  • Recovery of kidney functions

    (improvement of eGFR, serum creatinine to normal or previous baseline).

    12 weeks

Secondary Outcomes (3)

  • progression to chronic kidney disease.

    12 weeks

  • mortality

    12 weeks

  • Need for renal replacement therapy

    12 weeks

Study Arms (2)

AKI group

patients who are hospitalized and develop acute kidney injury after 48 hours from admission

Other: standard AKI care bundle

no AKI group

patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge

Other: standard care for hospitalized patients

Interventions

AKI care bundle include use of iv fluids, diuretics, antihyperkalemic drugs, sodium bicarbonate, antibiotics in septic patients.

AKI group

this includes iv fluids, diuretics, antibiotics in septic patients, other measures according to original disease

no AKI group

Eligibility Criteria

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

This research is a prospective cohort study that will include hospitalized patients in Alexandria Main University Hospital (in non-intensive care unit sittings) admitted over a period of sixteen weeks. Patients will be divided into two groups: Group (A) : patients who are hospitalized and develop acute kidney injury after 48 hours from admission. Group (B) : patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge. All participants will be followed till discharge and after 3 months to assess outcomes.

You may qualify if:

  • Fulfilment of definition of acute kidney injury according to KDIGO reference.
  • Age more than 18 years.

You may not qualify if:

  • Mentally or physically unfit patients.
  • Patients who developed acute kidney injury within 48 hours of admission to hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (4)

  • Singh TB, Rathore SS, Choudhury TA, Shukla VK, Singh DK, Prakash J. Hospital-acquired acute kidney injury in medical, surgical, and intensive care unit: A comparative study. Indian J Nephrol. 2013 Jan;23(1):24-9. doi: 10.4103/0971-4065.107192.

    PMID: 23580801BACKGROUND
  • Sawhney S, Mitchell M, Marks A, Fluck N, Black C. Long-term prognosis after acute kidney injury (AKI): what is the role of baseline kidney function and recovery? A systematic review. BMJ Open. 2015 Jan 6;5(1):e006497. doi: 10.1136/bmjopen-2014-006497.

    PMID: 25564144BACKGROUND
  • Hsu CN, Lee CT, Su CH, Wang YL, Chen HL, Chuang JH, Tain YL. Incidence, Outcomes, and Risk Factors of Community-Acquired and Hospital-Acquired Acute Kidney Injury: A Retrospective Cohort Study. Medicine (Baltimore). 2016 May;95(19):e3674. doi: 10.1097/MD.0000000000003674.

    PMID: 27175701BACKGROUND
  • Ponce D, Balbi A. Acute kidney injury: risk factors and management challenges in developing countries. Int J Nephrol Renovasc Dis. 2016 Aug 22;9:193-200. doi: 10.2147/IJNRD.S104209. eCollection 2016.

    PMID: 27578995BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Hala S ElWakil, MD

    professor

    PRINCIPAL INVESTIGATOR
  • yasmine s naga, MD

    ASS. prof

    STUDY CHAIR
  • Mohamed mamdouh Elsayed, MD

    Lecturer

    STUDY CHAIR
  • sara R Nagib, MBBCh

    Resident

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 25, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 15, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations