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

Open-label, Multicenter, Randomized, Controlled Trial of Hemodynamic Optimization Based on the Hypotension Prediction Index (HPI) Compared to Standard Practice in Adult Patients Undergoing Elective Major Abdominal Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Acute Kidney Injury
• Intervention / Treatment: Procedure: Intraoperative hemodynamic management

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain
    • Hospital Universitario de Badajoz
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Universitario de Sant Pau
  • Barcelona, Spain
    • Hospital Universitario Moises Brogi
  • Bilbao, Spain
    • Hospital Uniuversitario de Basurto
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Girona, Spain
    • Hospital Universitario Doctor Trueta
  • Granada, Spain
    • Hospital San Cecilio
  • Granada, Spain
    • Hospital Universitario Virgen de Las Nieves
  • Huelva, Spain
    • Hospital Universitario Juan Ramón Jiménez
  • Igualada, Spain
    • Hospital Universitario de Igualada
  • Jerez De La Frontera, Spain
    • Hospital Universitario Jerez de la Frontera
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrín
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro
  • Manresa, Spain
    • Althai Xarxa Universitaria
  • San Sebastián, Spain
    • Hospital Universitario DE Donostia
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Santiago De Compostela, Spain
    • Hospital Clinico Universitario de Santiago
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain
    • Hospital Universitario Virgen de la Macaarena
  • Valencia, Spain
    • Hospital General Universitario de Valencia
  • Valladolid, Spain
    • Hospital Universitario Ríio Hortega
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodynamic prediction index based goal directed hemodynamic therapy; Hemodynamic handling will be based hemodynamic prediction index (HPI)	Procedure: Intraoperative hemodynamic management; Goal directed Hemodynamic therapy; Other Names: Fluid therapy
No Intervention: No HPI; Patients in the control group will be treated according to standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for renal replacement therapy (RRT)	yes/no	30 days after surgery
renal replacement therapy (RRT) duration	days	30 days after surgery
Renal recovery on day 30	yes/no	30 days after surgery
Mortality	yes/no	30 days after surgery
Postoperative complications	According to:Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures	30 days after surgery
Postoperative length of stay	days	30 days after surgery
Number of days free from critical care	days	30 days after surgery

Collaborators and Investigators

• Sponsor: Maria José Clara Colomina Soler
• Investigators: Study Chair: Javier Ripollés Melchor, MD, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative care; Acute kidney injury; Major surgery; Hemodynamic prediction index
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Hypotension; Postoperative Complications
• Other Study ID Numbers: GFMH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon specific request following the publication of the study
• IPD Sharing Time Frame: From publication on clinicaltrials.org until 1 year after publication of the results.
• IPD Sharing Access Criteria: under request and Steering Committe review
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No