Clinical Trials Logo
  1. Home
  2. Hemodynamic Instability
  3. NCT02675374

Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation — HIPPIE  

Hemodynamic Instability Clinical Trial

Clinical Trial Summary

This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.

Clinical Trial Description

Vasoplegic syndrome is recognized as a common complication after CPB. Its incidence ranges from 5% to 25% after cardiac surgery requiring CPB. Such syndrome is related to an inflammatory reaction, which is attributed to the CPB. This syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs.

Investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. Tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. According to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances.

The hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. This study aims to determine the effect of an antihistamine (dexchlorpheniramine (Polaramine®)) administered intravenously before CPB, on the vasoplegic syndrome incidence after separation from CPB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02675374
Study type Interventional
Source University Hospital, Bordeaux
Contact
Status Completed
Phase Phase 3
Start date June 5, 2016
Completion date July 18, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT03653910 - Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope N/A
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Terminated NCT02365688 - Hemodynamic Response During Goal Directed Fluid Therapy in the OR N/A
Completed NCT01605279 - Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns Phase 2
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Recruiting NCT04010058 - Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward N/A
Completed NCT06268275 - Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy N/A
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room
Not yet recruiting NCT05003011 - Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
Completed NCT03599440 - Effect of Extended Infusion Lines on Pulse Contour-based Measurements
Completed NCT05035485 - Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia N/A
Not yet recruiting NCT04227821 - Hemodynamic Optimalization in Pediatric Patients
Completed NCT06158165 - Evaluating The Cardiovascular Effects of Tourniquet Application
Completed NCT05481047 - Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery N/A
Not yet recruiting NCT04076709 - Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery Phase 4
Not yet recruiting NCT03828032 - Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients. N/A
Completed NCT04089098 - VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Recruiting NCT05570682 - Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy N/A
Completed NCT04574908 - A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards N/A