Hypotension Clinical Trial
Official title:
Physician-Directed vs Computer-Assisted Norepinephrine Administration in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial
Intraoperative hypotension can impact patient outcome. Vasopressors are usually used to
correct hypotension and ensure adequate organ perfusion.
The investigators have recently developed an automated system (closed-loop system) to titrate
vasopressor agents in surgical and intensive care patients.
The purpose of this study is to compare two strategies to correct hypotension based on an
individual definition of hypotension (therefore, the target MAP used to define hypotension
will differ for each patient (individualized approach):
1. Control group = standard practice ( manually adjusted norepinephrine infusion to correct
hypotension and keep MAP within 90% of patient's baseline MAP
2. Intervention group = closed-loop (automated) vasopressor administration system will
deliver norepinephrine using feedback from standard operating room hemodynamic monitor
(EV1000 Monitor-Flotrac, Edwards Lifesciences, IRVINE, USA) to correct hypotension and
keep MAP within 90% of patient's baseline MAP
In order to prevent the known postoperative complications of intraoperative hypotension,
vasopressor agents are occasionally used to ensure adequate perfusion. These vasopressors are
usually administered as manually adjusted infusions, but this practice requires considerable
time and attention.
To overcome this issue, the investigators have developed a closed-loop vasopressor (CLV)
controller to potentially correct hypotension more efficiently. After completing extensive
in-silico, in-vivo studies and a pilot human trial in a small cohort of 20 patients, the
investigators aimed to conduct now a randomized control trial comparing manual vasopressor
adjustment versus closed-loop vasopressor adjustment in high risk patients undergoing major
abdominal surgeries in order to correct hypotension during surgery
The primary outcome will be the incidence of hypotension (defined as a reduction of > 10%
from patient's MAP target, or a allowed tolerance of 10% reduction from patient's baseline
MAP). This has been chosen based on the recent study of Emmanuel Futier and colleagues
(Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative
Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical
Trial. JAMA. 2017 Oct 10;318(14):1346-1357), even if it was originally done with systolic
blood pressure
Participants in both groups will receive standard patient care in that in no way will their
anesthetic or surgical procedure will be altered as part of the study, with the exception of
vasopressor administration.
Fluids will be standardized in both groups and will be given as a continuous baseline
infusion of 3 ml/kg/h (balanced crystalloid solution) and additional fluid boluses (mini
fluid challenges of 100 ml) as a goal directed fluid therapy strategy to maintain stroke
volume variation < 13%. The only difference is the way norepinephrine is delivered to the
patient (manual versus closed-loop assisted)
;
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 |
NCT02907931 -
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status
|
N/A | |
Completed |
NCT03215797 -
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
|
Phase 3 | |
Suspended |
NCT02315937 -
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
|
N/A | |
Recruiting |
NCT02532270 -
Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
|
N/A | |
Completed |
NCT02802683 -
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02437799 -
Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia
|
N/A | |
Completed |
NCT02146898 -
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
|
N/A | |
Not yet recruiting |
NCT01941472 -
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness
|
N/A | |
Completed |
NCT01930227 -
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
|
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
|
||
Active, not recruiting |
NCT05250960 -
Pre-epidural SCDs to Prevent Hypotension During Labor
|
N/A |