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Drinking water may shield kidneys during emergency heart procedures

NCT ID NCT07761754

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This trial tests whether a structured oral hydration plan—drinking at least 1,500 mL of fluid within 12 hours around the procedure—can reduce the risk of contrast-induced acute kidney injury (CI-AKI) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. Participants are randomly assigned to either the hydration protocol or standard care. The study measures kidney function via serum creatinine before and after contrast exposure, and monitors for adverse events like fluid overload or heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A structured oral hydration protocol with a target intake of at least 1,500 mL within 12 hours around primary PCI, supported by nursing and standardized documentation.
What this could lead to
If effective, this simple, low-cost hydration strategy could become a standard preventive measure to protect kidney function in heart attack patients undergoing stent procedures.
What could go wrong
This is a single-center trial, and the results may not apply broadly. There is also a risk that increased fluid intake could lead to fluid overload or heart failure in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 384 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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