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

NCT05569265 | Completed DMC

• 1 other identifier: GFMH1
• Study Type: interventional
• Target: 958
• Locations: 1 country
• Sites: 26

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

Keywords

Perioperative care; Acute kidney injury; Hemodynamic prediction index; Major surgery

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  The primary outcome is the occurrence of moderate or severe AKI (according to KDIGO Stage 2-3 criteria) within 30 days after surgery. AKI is classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as follows: Stage 1: Increase in serum creatinine by 1.5 to 1.9 times baseline or increase in serum creatinine by 0.3 mg/dL, or reduction in urine output to \<0.5 mL/kg/hour for 6 to 12 hours. Stage 2: Increase in serum creatinine by 2.0 to 2.9 times baseline, or reduction in urine output to \<0.5 mL/kg/hour for \>12 hours. Stage 3: Increase in serum creatinine to 3.0 times baseline, or increase in serum creatinine to \>4.0 mg/dL or reduction in urine output to \<0.3 mL/kg/hour for \>24 hours, or anuria for \>12 hours, or initiation of renal replacement therapy, or, in patients \<18 years, decrease in estimated glomerular filtration rate (eGFR) to \<35 mL/min/1.73 m2.

  7 days after surgery

Secondary Outcomes (7)

• Need for renal replacement therapy (RRT)

  30 days after surgery

• renal replacement therapy (RRT) duration

  30 days after surgery

• Renal recovery on day 30

  30 days after surgery

• Mortality

  30 days after surgery

• Postoperative complications

  30 days after surgery

Study Arms (2)

Hemodynamic prediction index based goal directed hemodynamic therapy

EXPERIMENTAL

Hemodynamic handling will be based hemodynamic prediction index (HPI)

Procedure: Intraoperative hemodynamic management

No HPI

NO INTERVENTION

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

Interventions

Intraoperative hemodynamic management PROCEDURE

Goal directed Hemodynamic therapy

Also known as: Fluid therapy

Hemodynamic prediction index based goal directed hemodynamic therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Stage 4 or 5 chronic kidney disease (eGFR \< 15 ml/ min)
• Renal transplantation in the previous 12 months
• Glomerulonephritis, interstitial nephritis or vasculitis
• Pre-existing AKI
• Renal replacement therapy (RRT) in the last 90 days
• 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

Sponsors & Collaborators

• Maria José Clara Colomina Soler: lead

Study Sites (26)

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario de Badajoz

Badajoz, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario de Sant Pau

Barcelona, Spain

Location

Hospital Universitario Moises Brogi

Barcelona, Spain

Location

Hospital Uniuversitario de Basurto

Bilbao, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Doctor Trueta

Girona, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Location

Hospital Universitario Juan Ramón Jimenez

Huelva, Spain

Location

Hospital Universitario de Igualada

Igualada, Spain

Location

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Location

Althai Xarxa Universitaria

Manresa, Spain

Location

Hospital Universitario de Donostia

San Sebastián, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen de la Macaarena

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario Ríio Hortega

Valladolid, Spain

Location

Related Publications (3)

• 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.

  PMID: 23835589 BACKGROUND

• 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.

  PMID: 32065827 BACKGROUND

• 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.

  PMID: 38685032 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Acute Kidney Injury

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Javier Ripollés Melchor, MD

  Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 8, 2022
• Primary Completion: January 15, 2024
• Study Completion: February 25, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From publication on clinicaltrials.org until 1 year after publication of the results.
• Access Criteria: under request and Steering Committe review

Locations

ES (26)