Status:
COMPLETED
The Predict H Trial
Lead Sponsor:
Juan Victor Lorente
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Intraoperative Hypotension
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intra...
Detailed Description
Background: Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index developed from machine learning, predicts the occurrence of arterial hy...
Eligibility Criteria
Inclusion
- Enrolled patients will be at least 65 years old and/or American Society of Anesthesiologist (ASA) physical status III/IV, scheduled for elective major abdominal surgery (general surgery, urology, or gynecology, through laparoscopic or open approach), with general or combined anesthesia. Surgery will be considered to be major if the expected duration is \> 2 h, or the estimated blood loss is \> 15% of blood volume, or if the expected required transfusion is ≥ 2 packed red blood cells.
- Exclusion criteria will be pregnancy, surgery performed only under regional anesthesia, preoperative glomerular filtrate \< 60 ml/min/1.73m2 according to the CKD-EPI 2009 formula, persistent atrial fibrillation, known cardiac shunts or if the patient received a kidney transplant, and refusal of the patient to participate in the study.
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04301102
Start Date
November 1 2020
End Date
June 1 2022
Last Update
December 9 2022
Active Locations (5)
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1
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
2
Hospital Universitario de Badajoz
Badajoz, Spain, 06080
3
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain, 21005
4
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031