Clinical trial NCT05569265: Hypotension Prediction Index-guided Hemodynamic Optimization Trial to Reduce Postoperative Acute Kidney Injury (HYT).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Acute Kidney Injury
Postoperative Complications
Keywords: Perioperative care
Acute kidney injury
Hemodynamic prediction index
Major surgery
Lead sponsor: Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Acute kidney injury
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Need for renal replacement therapy (RRT)
timeFrame: 30 days after surgery
measure: renal replacement therapy (RRT) duration
timeFrame: 30 days after surgery
measure: Renal recovery on day 30
timeFrame: 30 days after surgery
measure: Mortality
timeFrame: 30 days after surgery
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Postoperative length of stay
timeFrame: 30 days after surgery
measure: Number of days free from critical care
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario Bellvitge
state: Barcelona
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Moises Brogi
city: Bilbao
country: Spain
facility: Hospital Uniuversitario de Basurto
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Girona
country: Spain
facility: Hospital Universitario Doctor Trueta
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jimenez
city: Igualada
country: Spain
facility: Hospital Universitario de Igualada
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario Jerez de la Frontera
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Manresa
country: Spain
facility: Althai Xarxa Universitaria
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macaarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Universitario Ríio Hortega
Study officials:
affiliation: Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
name: Javier Ripollés Melchor, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.