Diagnostic Performance of Two Tools

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05268211
• Collaborator: (none)
• Enrollment: 130
• Anticipated Duration (Months): 33.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Diagnostic Test: urinary oxygen partial pressure

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnostic Performance of Two Tools for Early Prediction of Acute Kidney Injury After Open-heart Surgery
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. Incidence of acute kidney injury [up to 48 hours]

   Incidence of AKI according to AKIN criteria

2. Urinary oxygen partial pressure [up to 48 hours]

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

3. Renal resistive index [up to 48 hours]

   Renal resistive index measured at induction and in the ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mina Medhat Mahfouz Eshak, Assitant Lectruer, Assiut University
• ClinicalTrials.gov Identifier: NCT05268211
• Other Study ID Numbers: IRB 5891
• First Posted: Mar 7, 2022
• Last Update Posted: Mar 7, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Mar 7, 2022