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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

- 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

Trial design

Treatments tested in this trial

  • oral hydration protocol

Treatment groups

384 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators