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

NCT ID: NCT05569265

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 958 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2024-02-25

Brief 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.

Conditions

Postoperative Acute Kidney Injury; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hemodynamic prediction index based goal directed hemodynamic therapy

Hemodynamic handling will be based hemodynamic prediction index (HPI)

Group Type: EXPERIMENTAL

Intraoperative hemodynamic management

Intervention Type: PROCEDURE

Goal directed Hemodynamic therapy

No HPI

Patients in the control group will be treated according to standard practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intraoperative hemodynamic management

Goal directed Hemodynamic therapy

Intervention Type: PROCEDURE

Other Intervention Names

Fluid therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria José Clara Colomina Soler

OTHER

Sponsor Role: lead

Responsible Party

Maria José Clara Colomina Soler

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Javier Ripollés Melchor, MD

Role: STUDY_CHAIR

Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

Locations

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Badajoz

Badajoz, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario de Sant Pau

Barcelona, , Spain

Hospital Universitario Moises Brogi

Barcelona, , Spain

Hospital Uniuversitario de Basurto

Bilbao, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario Doctor Trueta

Girona, , Spain

Hospital San Cecilio

Granada, , Spain

Hospital Universitario Virgen de Las Nieves

Granada, , Spain

Hospital Universitario Juan Ramón Jimenez

Huelva, , Spain

Hospital Universitario de Igualada

Igualada, , Spain

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, , Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, , Spain

Hospital Infanta Leonor

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Majadahonda, , Spain

Althai Xarxa Universitaria

Manresa, , Spain

Hospital Universitario de Donostia

San Sebastián, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario Virgen de la Macaarena

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario Ríio Hortega

Valladolid, , Spain

Countries

Spain

References

Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

Reference Type: BACKGROUND

PMID: 23835589 (View on PubMed)

Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.

Reference Type: BACKGROUND

PMID: 32065827 (View on PubMed)

Ripolles-Melchor J, Carrasco-Sanchez L, Tome-Roca JL, Aldecoa C, Zorrilla-Vaca A, Lorente-Olazabal JV, Colomina MJ, Perez A, Jimenez-Lopez JI, Navarro-Perez R, Abad-Gurumeta A, Monge-Garcia MI; HYT Study Group. Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial. Trials. 2024 Apr 29;25(1):288. doi: 10.1186/s13063-024-08113-w.

Reference Type: DERIVED

PMID: 38685032 (View on PubMed)

Other Identifiers

GFMH1

Identifier Type: -

Identifier Source: org_study_id