Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia

Status Recruiting

Clinical Trial Summary

Cardiopulmonary bypass (CPB) surgery present risk of acute postoperative neurological complications. These complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. The causes are usually multifactorial, but altered cerebral perfusion during CPB surgery is an important prognostic factor. Data regarding the effect of deep hypothermia on cerebral perfusion during CPB in adult are scarce. Currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (PAE) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia. In this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries. To protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°C. Deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. It also increases the solubility of CO2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions. In adult there is no consistent data on the cerebral perfusion during PAE surgery under deep hypothermia at 18-20°C. Animal studies showed that cerebral regulation seems to be preserved under these conditions. A better understanding of the effect of deep hypothermia on cerebral perfusion during PAE surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06250374
Study type	Interventional
Source	Fondation Hôpital Saint-Joseph
Contact	Sylvain DIOP, Dr
Phone	+33140948637
Email	sdiop@ghpsj.fr
Status	Recruiting
Phase	N/A
Start date	August 24, 2023
Completion date	May 24, 2025

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01950585` - Hydroxyurea in Pulmonary Arterial Hypertension	Early Phase 1
Completed	`NCT00527163` - Role of Nitric Oxide in Malaria
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Recruiting	`NCT04554160` - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Completed	`NCT01894035` - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting	`NCT04083729` - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy	N/A
Completed	`NCT02216279` - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension	Phase 2
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	N/A
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Completed	`NCT02821156` - Study on the Use of Inhaled NO (iNO)	N/A
Recruiting	`NCT01913847` - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension	Phase 3
Completed	`NCT01615484` - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability	N/A
Completed	`NCT06240871` - Contrast Enhanced PA Pressure Measurements
Completed	`NCT02377934` - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Recruiting	`NCT01091012` - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension	Phase 3
Completed	`NCT00739375` - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension.	Phase 1
Completed	`NCT01484899` - Smoking: a Risk Factor for Pulmonary Arterial Hypertension?	N/A
Completed	`NCT01463514` - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension	N/A
Completed	`NCT02275793` - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery. — HYPO-TEP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms