CompletedNot Applicable

Hypotension Prediction Index-guided Hemodynamic Optimization Trial to Reduce Postoperative Acute Kidney Injury (HYT).

Spain958 participantsStarted 2022-10-08

Plain-language summary

MAIN AIM OF THE STUDY To establish whether hemodynamic management guided by the hypotension prediction index (HPI) guided by the administration of intravenous fluids and vasoactive drugs in patients undergoing elective major abdominal surgery reduces the incidence of postoperative moderate-severe acute kidney injury (AKI) in the 30 days after surgery. STUDY DESIGN A low intervention level clinical, blinded, controlled, randomized, multicenter, with daily follow-up of patients until hospital discharge and of postoperative complications and mortality 30 days after surgery will be performed. This is a low-intervention clinical trial comparing standard treatments: * The drugs used in the investigation are licensed. * The drugs are used according to the indications contemplated in the technical data sheet and there are published scientific data on their efficacy and safety. * The complementary diagnostic or follow-up procedures entail a very limited additional risk or burden to the safety of the subjects, which is minimal compared to that of standard clinical practice. STUDY DISEASE Intraoperative hemodynamic monitoring and management in surgical patients undergoing major abdominal surgery. STUDY POPULATION AND TOTAL NUMBER OF PATIENTS The sample of this study consists of patients of both genders, aged over 65 years and/or physical status ASA III or IV, undergoing elective major abdominal surgery (abdominal, urological, gynecological) under general/combined anesthesia (using laparoscopic or open approaches. To detect a 5% absolute reduction (from 10% to 5%) in the primary outcome variable (postoperative AKI up to 30 days) with a sample size ratio of 1%, and an overall type I error rate of 5%, we need 870 patients (435 per arm). Assuming a 10% loss rate, the total amounts to 958 patients, 479 for each group. DURATION OF THE STUDY The total planned duration of the overall study, which includes authorization, recruitment of subjects, and follow-up of subjects until completion of the analysis of the results obtained, is 19 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients over 65 years of age and/or physical condition ASA III or IV. * Patients who have major elective abdominal surgery indicated: general surgery, urology, gynecology, by laparoscopic or open approaches. * Patients who sign the informed consent, agreeing to participate in the study. Exclusion Criteria: * Stage 4 or 5 chronic kidney disease (eGFR \< 15 ml/ min) * Renal transplantation in the previous 12 months * Glomerulonephritis, interstitial nephritis or vasculitis * Anuria at inclusion * Pre-existing AKI * Renal replacement therapy (RRT) in the last 90 days * Indication for renal replacement at the time of inclusion * Participation in another interventional trial investigating a drug/intervention affecting renal function * Patients with atrial fibrillation * Patients with known cardiac shunts. * Patients whose surgical indication is urgent * Pregnancy or lactation * Patients expected to die within 30 days. * Acute myocardial ischemia within the previous 30 days. * Acute pulmonary edema within the previous 30 days * Any contraindication to vasoactive or inotropic medication at low doses

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute kidney injury

Timeframe: 7 days after surgery

Trial details

NCT IDNCT05569265

SponsorMaria José Clara Colomina Soler

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-15

View on ClinicalTrials.gov More Postoperative Acute Kidney Injury trials