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The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)

NCT07761754 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2026-08-12

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). The main questions it aims to answer are:

Does a structured oral hydration regimen reduce the incidence of CI-AKI compared with standard care without a prescribed hydration regimen? Does oral hydration improve renal outcomes without increasing the risk of adverse events, such as heart failure or fluid overload, in patients undergoing PPCI?

Researchers will compare patients receiving a structured oral hydration regimen with patients receiving standard care without a prescribed hydration regimen to determine whether oral hydration decreases the incidence of CI-AKI and improves clinical outcomes.

Participants will:

Be randomly assigned to either the oral hydration group or the standard care group.

Undergo primary percutaneous coronary intervention according to institutional practice.

Receive the assigned hydration strategy after the procedure. Have serum creatinine measured at baseline and after contrast exposure to assess for CI-AKI.

Be monitored for adverse events, including fluid overload, heart failure, need for renal replacement therapy, length of hospital stay, and other relevant clinical outcomes.

Conditions

  • Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction

Interventions

OTHER

oral hydration protocol

The intervention consists of a standardized, nurse-supported oral hydration protocol with a target intake of at least 1,500 mL within 12 hours surrounding primary percutaneous coronary intervention (PPCI). Unlike routine care, participants receive scheduled hydration targets, standardized documentation of fluid intake, nursing reinforcement to optimize adherence, and verification of protocol completion by the research coordinator. This structured approach is designed to provide a consistent, practical, and low-cost hydration strategy for the prevention of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI).

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761754 on ClinicalTrials.gov