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

NCT07761754 | Not Yet Recruiting

• 1 other identifier: hydration & preventing CI-AKI
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast-induced acute kidney injury (CI-AKI)

  Incidence of CI-AKI, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days after contrast exposure.

  Within 48 hours after primary percutaneous coronary intervention (PPCI)

Study Arms (2)

Structured Oral Hydration , Arm 1

ACTIVE COMPARATOR

Participants randomized to the intervention arm will receive a structured oral hydration regimen in addition to standard medical care. The protocol consists of a target oral fluid intake of at least 1,500 mL within 12 hours of primary percutaneous coronary intervention (PPCI), including 500 mL of plain water 30-60 minutes before arterial sheath insertion, 500 mL of water within the first 4 hours after sheath removal, and at least 500 mL of water during 4-12 hours after the procedure. Oral fluid intake will be encouraged by nursing staff, documented on a standardized fluid intake chart, and reviewed by the research coordinator at the 12-hour time point. Participants will otherwise receive standard guideline-directed care for STEMI.

Other: oral hydration protocol

Standard Care / No Prescribed Oral Hydration Regimen (control arm)

NO INTERVENTION

Participants randomized to the control arm will receive standard medical care for ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) according to institutional practice. No structured oral hydration regimen will be prescribed. Oral fluid intake will be permitted according to routine clinical care and at the discretion of the treating healthcare team. All other aspects of patient management, including medications, monitoring, and follow-up, will be provided in accordance with current institutional protocols and clinical guidelines.

Interventions

oral hydration protocol OTHER

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).

Structured Oral Hydration , Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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
• 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)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (16)

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• Pioli MR, Couto RM, Francisco JA, Antoniassi DQ, Souza CR, Olivio MY, Anhe GF, Giopatto S, Sposito AC, Nadruz W, Coelho-Filho OR, Modolo R. Effectiveness of Oral Hydration in Preventing Contrast-Induced Nephropathy in Individuals Undergoing Elective Coronary Interventions. Arq Bras Cardiol. 2023 Feb 27;120(2):e20220529. doi: 10.36660/abc.20220529. eCollection 2023. English, Portuguese.

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• Rear R, Bell RM, Hausenloy DJ. Contrast-induced nephropathy following angiography and cardiac interventions. Heart. 2016 Apr;102(8):638-48. doi: 10.1136/heartjnl-2014-306962. Epub 2016 Feb 8. No abstract available.

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• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08