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NCT07761754

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

Sponsor: Assiut University

View on ClinicalTrials.gov

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.

Official title: The Effect of Hydration on the Prevention of Contrast Induced Acute Kidney Injury (CI-AKI) in ST Segment Elevation Myocardial Infarction Undergoing Primary PCI (Hydro-AKI Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

384

Start Date

2026-09

Completion Date

2029-06

Last Updated

2026-09-08

Healthy Volunteers

Conditions

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

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).

Inclusion Criteria: Inclusion Criteria All of the following must be present: * Age ≥18 years at the time of randomization * Clinical diagnosis of STEMI, confirmed by 12-lead ECG showing ≥30 minutes of ST-segment elevation ≥1 mm in ≥2 contiguous limb leads or ≥2 mm in ≥2 contiguous precordial leads, or new left bundle branch block with a clinical presentation consistent with acute myocardial infarction * Decision to proceed with primary PCI as the reperfusion strategy, within 12 hours of symptom onset (or up to 24 hours if evidence of persistent ischaemia or haemodynamic instability) * Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m², calculated by the CKD-EPI 2021 formula from the most recent available serum creatinine measurement prior to contrast exposure * Ability to swallow and safely tolerate oral fluids, as assessed by the attending physician * Oral informed consent obtained from the patient or a legally authorized representative (deferred consent protocol applies in emergencies per IRB approval) Exclusion Criteria: * \- Cardiogenic shock on presentation, defined as systolic blood pressure \<90 mmHg for \>30 minutes despite fluid resuscitation, or requirement for vasopressor or inotropic therapy to maintain SBP ≥90 mmHg, with evidence of end-organ hypoperfusion (Killip Class IV) * Acute pulmonary oedema or Killip Class III with SpO₂ \<90% on room air, bilateral crepitations \>50% of lung fields, or chest X-ray showing pulmonary venous congestion requiring urgent diuresis * Pre-existing dialysis dependence (haemodialysis or peritoneal dialysis) or eGFR \<30 mL/min/1.73m² on admission * Active vomiting, dysphagia, altered consciousness (GCS \<14), or any clinical condition precluding safe oral fluid intake, as assessed by the attending physician * Administration of any IV hydration protocol for CIN prevention prior to randomization (patients may have received standard IV fluids for other indications; these are documented but do not constitute exclusion unless specifically intended as CIN prophylaxis) * Known severe allergy to iodinated contrast media that cannot be managed with pre-medication (moderate/mild allergies and prior mild reactions are not exclusions) * Concurrent administration of known nephrotoxic agents within 48 hours that cannot be withheld or dose-adjusted: aminoglycoside antibiotics (gentamicin, amikacin), high-dose loop diuretics in the context of diuretic nephropathy, or cisplatin-based chemotherapy * Pregnancy (confirmed by urine or serum beta-hCG) or active breastfeeding * Estimated life expectancy \<30 days from a non-cardiac cause (advanced malignancy, end-stage liver disease, multiorgan failure)