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Vasoplegia clinical trials

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NCT ID: NCT05925348 Recruiting - Vasoplegia Clinical Trials

Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)

Start date: October 2, 2023
Phase:
Study type: Observational

This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

NCT ID: NCT05922982 Recruiting - Surgery Clinical Trials

Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

NORAHPI
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension. This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock. The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.

NCT ID: NCT05833828 Recruiting - Vasoplegia Clinical Trials

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

RAAS-HLM
Start date: August 24, 2023
Phase:
Study type: Observational

This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery

NCT ID: NCT05568160 Recruiting - Vasoplegic Syndrome Clinical Trials

Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

NOVACC
Start date: January 2, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline. It is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome. The primary objective of this study is to determine whether the use of vasopressin to maintain blood pressure following cardiac surgery decreases the number of patients with acute renal failure and/or death compared with the usual use of norepinephrine. Participation in the study involves daily follow-up at D1, D2, and D7 of the onset of the syndrome and then follow-up at D30 and D90.

NCT ID: NCT05146336 Recruiting - Sepsis Clinical Trials

CytOSorb TreatMent Of Critically Ill PatientS Registry

COSMOS
Start date: June 22, 2022
Phase:
Study type: Observational [Patient Registry]

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

NCT ID: NCT05058612 Recruiting - Vasoplegia Clinical Trials

Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)

Start date: March 22, 2021
Phase: Phase 4
Study type: Interventional

Vasopressors are medications that are given intravenously to increase the blood pressure of patients with illnesses that cause dangerous blood pressure drops. When a doctor prescribes a vasopressor, they ask that the dose be adjusted to achieve a specific blood pressure. This kind of medical support with intravenous (IV) vasopressors are usual treatments in intensive care unit (ICU) settings. Oral vasopressors, such as midodrine, have been historically used to maintain blood pressure in non-critically ill patients. In this study, the investigators will be using midodrine to reduce the need for IV vasopressors as blood pressure improves during the stay in the ICU. The LIBERATE multi-site study will continue the work of the pilot study to evaluate the role of midodrine for patients with low blood pressure in the ICU.

NCT ID: NCT04964492 Recruiting - Shock Clinical Trials

Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

VASOKIT
Start date: July 13, 2021
Phase:
Study type: Observational

Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock). HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome. The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.

NCT ID: NCT04901169 Recruiting - Clinical trials for Liver Transplant; Complications

Angiotensin II in Liver Transplantation

AngLT-1
Start date: June 28, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of Angiotensin II as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.

NCT ID: NCT04812717 Recruiting - Heart Failure Clinical Trials

Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb.

CytoSorb-HF
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Vasoplegia is a common complication after heart surgery for heart failure. With vasoplegia, the blood vessels can no longer squeeze properly, causing low blood pressure that is sometimes difficult to treat with medication. One of the causes of this complication is likely to be the use of the heart-lung machine, a device that takes over the function of the heart and lungs during surgery. The blood then comes into contact with a foreign environment and this can cause a reaction of the immune system. Patients with heart failure are extra sensitive to this reaction. CytoSorb device is a filter that can be built into the heart-lung machine and can reduce the response of the immune system. Therefore, this study aims to investigate whether the use of this filter during heart surgery in patients with heart failure results in a less frequent occurrence of vasoplegia after surgery.

NCT ID: NCT04519281 Recruiting - Clinical trials for to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPB

Role of Vitamin C in Cardiac Vasoplegia After Cardiopulmonary Bypass

Start date: April 16, 2020
Phase:
Study type: Observational [Patient Registry]

This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Two groups will be included; Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid (treatment group) and Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (control group). Each patient will be subjected to assessments of the doses of noradrenaline given from the end of surgery until weaning as well as hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery.