Clinical Trials Logo

Clinical Trial Summary

This trial registration serves as an amendment incorporating the IPD Sharing Statement. This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted. Study summary: Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.


Clinical Trial Description

Population studied: All adult patients undergoing elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target MAP of 65 mmHg or above during both surgery (excluding cardiopulmonary bypass pump time (CBP)) and during mechanically ventilated phase of duration of ICU admission. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05821647
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact
Status Completed
Phase N/A
Start date May 20, 2021
Completion date March 16, 2023

See also
  Status Clinical Trial Phase
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting NCT02016599 - Effects of Transitional Circulation in ELBW Infants
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A
Recruiting NCT02532270 - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring N/A
Completed NCT02437799 - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia N/A
Completed NCT02802683 - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery Phase 4
Completed NCT02146898 - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery N/A
Completed NCT01930227 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients N/A
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Recruiting NCT01434251 - Treatment of Hypotension of Prematurity (TOHOP) N/A
Withdrawn NCT01183741 - Accuracy of Non-Invasive Blood Pressure Measurement in Adults Phase 3
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Withdrawn NCT00750516 - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Recruiting NCT05513066 - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed NCT04089644 - Manual vs Closed-loop Control of Mean Arterial Pressure N/A