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NCT Number: NCT05569265

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative hemodynamic management

Procedure

Goal directed Hemodynamic therapy

Other names: Fluid therapy

Primary outcomes

  1. Acute kidney injury

    Time frame: 7 days after surgery

    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.

Secondary outcomes

  1. Need for renal replacement therapy (RRT)

    Time frame: 30 days after surgery

    yes/no

  2. renal replacement therapy (RRT) duration

    Time frame: 30 days after surgery

    days

  3. Renal recovery on day 30

    Time frame: 30 days after surgery

    yes/no

  4. Mortality

    Time frame: 30 days after surgery

    yes/no

  5. Postoperative complications

    Time frame: 30 days after surgery

    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

  6. Postoperative length of stay

    Time frame: 30 days after surgery

    days

  7. Number of days free from critical care

    Time frame: 30 days after surgery

    days

Sponsors and collaborators

Lead sponsor

Maria José Clara Colomina Soler

Other

Registry information

Official study title

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.

Acronym: HYT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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