Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

4. september 2026 oppdatert av: Alaa Khaled Mohamed, Assiut University

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)

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Contrast-induced acute kidney injury (CI-AKI) remains one of the most common complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The development of CI-AKI is associated with prolonged hospitalization, increased healthcare costs, higher rates of cardiovascular complications, and increased short- and long-term mortality. Despite advances in interventional cardiology, effective preventive strategies for CI-AKI in the emergency PPCI setting remain limited.

Adequate hydration is considered the cornerstone of CI-AKI prevention because it improves renal perfusion, suppresses vasoconstrictive mechanisms, dilutes intratubular contrast media, and promotes urinary excretion of contrast agents. However, the evidence supporting hydration strategies has been derived primarily from elective coronary procedures, where patients can receive intravenous hydration before and after contrast administration. In STEMI patients undergoing PPCI, the urgent nature of treatment often precludes pre-procedural hydration, and aggressive intravenous fluid administration may increase the risk of volume overload in patients with impaired cardiac function.

Oral hydration represents a simple, inexpensive, and widely accessible alternative that may offer renal protection while minimizing the logistical challenges associated with intravenous hydration in the acute setting. However, evidence regarding its effectiveness in patients undergoing emergency PPCI remains scarce, particularly in low- and middle-income countries.

This prospective, randomized, controlled clinical trial is designed to evaluate whether a structured oral hydration regimen initiated after PPCI reduces the incidence of CI-AKI compared with standard care without a prescribed hydration regimen. Eligible adult patients presenting with STEMI and undergoing successful PPCI will be randomly assigned in a 1:1 ratio to receive either the oral hydration protocol or standard care. All participants will receive routine evidence-based management for STEMI according to current institutional practice and contemporary clinical guidelines.

Renal function will be assessed using serum creatinine measurements obtained at baseline and after contrast exposure. CI-AKI will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Participants will also be monitored for safety outcomes, including signs and symptoms of heart failure or fluid overload, as well as clinically relevant in-hospital outcomes. Additional analyses will evaluate the relationship between oral hydration adherence and renal outcomes.

The primary outcome is the incidence of CI-AKI following PPCI. Secondary outcomes include changes in renal function, requirement for renal replacement therapy, duration of hospitalization, major in-hospital adverse clinical events, and safety outcomes related to hydration therapy.

The findings of this study are expected to provide evidence regarding the effectiveness and safety of structured oral hydration as a practical, low-cost preventive strategy for CI-AKI in patients with STEMI undergoing primary PCI, particularly in resource-limited healthcare settings.

Studietype

Intervensjonell

Registrering (Antatt)

384

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Structured Oral Hydration , Arm 1
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.
Annen: 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).
Ingen inngripen: Standard Care / No Prescribed Oral Hydration Regimen (control arm)
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of contrast-induced acute kidney injury (CI-AKI)
Tidsramme: Within 48 hours after primary percutaneous coronary intervention (PPCI)
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assiut University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

8. august 2026

Først innsendt som oppfylte QC-kriteriene

8. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • hydration & preventing CI-AKI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere