NCT05268211

Brief Summary

Developing new tools for early detection of AKI in open-heart surgeries.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Status
unknown

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 15, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 15, 2022

Last Update Submit

February 24, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

  • Incidence of acute kidney injury

    Incidence of AKI according to AKIN criteria

    up to 48 hours

  • Urinary oxygen partial pressure

    Urinary oxygen partial pressure measured in mmHg at induction, before rewarming and in the ICU

    up to 48 hours

  • Renal resistive index

    Renal resistive index measured at induction and in the ICU

    up to 48 hours

Interventions

urinary oxygen partial pressureDIAGNOSTIC_TEST

measuring urinary oxygen partial pressure and measuring US Doppler renal resistive index

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Enrollment of patients will be done through Assiut university Heart hospital after approval from the local ethics committee of the Faculty of Medicine, Assiut University

You may qualify if:

  • Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes

You may not qualify if:

  • Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Lectruer

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 7, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

December 1, 2024

Last Updated

March 7, 2022

Record last verified: 2022-02