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

Postoperative Complications Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569265
• Other study ID #: GFMH1
• Status: Completed
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: February 25, 2024

Study information

• Verified date: February 2024
• Source: Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. completion date: February 25, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Postoperative Acute Kidney Injury
• Postoperative Complications

Intervention

Procedure:
• Intraoperative hemodynamic management
Goal directed Hemodynamic therapy

Locations

Country	Name	City	State
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario de Sant Pau	Barcelona
Spain	Hospital Universitario Moises Brogi	Barcelona
Spain	Hospital Uniuversitario de Basurto	Bilbao
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Doctor Trueta	Girona
Spain	Hospital San Cecilio	Granada
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Juan Ramón Jimenez	Huelva
Spain	Hospital Universitario de Igualada	Igualada
Spain	Hospital Universitario Jerez de la Frontera	Jerez De La Frontera
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas De Gran Canaria
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Althai Xarxa Universitaria	Manresa
Spain	Hospital Universitario de Donostia	San Sebastián
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Universitario Virgen de la Macaarena	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario Ríio Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Maria José Clara Colomina Soler

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for renal replacement therapy (RRT)	yes/no	30 days after surgery
Secondary	renal replacement therapy (RRT) duration	days	30 days after surgery
Secondary	Renal recovery on day 30	yes/no	30 days after surgery
Secondary	Mortality	yes/no	30 days after surgery
Secondary	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
Secondary	Postoperative length of stay	days	30 days after surgery
Secondary	Number of days free from critical care	days	30 days after surgery