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

Sponsor

Maria José Clara Colomina Soler (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05569265

Collaborator

(none)

958

Enrollment

Locations

Arms

13.8

Anticipated Duration (Months)

159.7

Patients Per Site

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Acute Kidney Injury Postoperative Complications	Procedure: Intraoperative hemodynamic management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

958 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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.

Anticipated Study Start Date :

Oct 8, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Acute kidney injury [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 Outcome Measures

Need for renal replacement therapy (RRT) [30 days after surgery]
yes/no
renal replacement therapy (RRT) duration [30 days after surgery]
days
Renal recovery on day 30 [30 days after surgery]
yes/no
Mortality [30 days after surgery]
yes/no
Postoperative complications [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
Postoperative length of stay [30 days after surgery]
days
Number of days free from critical care [30 days after surgery]
days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
2	Hospital Universitario de Badajoz	Badajoz		Spain
3	Hospital San Cecilio	Granada		Spain
4	Hospital Infanta Leonor	Madrid		Spain
5	Althai Xarxa Universitaria	Manresa		Spain
6	Hospital General Universitario de Valencia	Valencia		Spain