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Hypotension clinical trials

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NCT ID: NCT06188663 Not yet recruiting - Clinical trials for Orthostatic Hypotension

SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

STOOD
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Background Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (< 6 weeks). Clinical Equipoise (Overall) High salt intake might improve quality of life and reduce the risk of falls, but might also increase the risk of cardiovascular disease, in patients with OH. Specific Objective of Current Application (Aim) To determine feasibility (recruitment, retention and adherence) of conducting a randomized controlled trial evaluating high salt intake in older adults with symptomatic orthostatic hypotension. To determine preliminary estimates of the effect of high salt intake on disease-specific quality of life, orthostatic blood pressure (BP) parameters, and cardiac blood biomarkers. Design: Phase IIa, parallel, double-blind, randomised controlled, single centre clinical trial of 12 month follow-up duration. Population: Older adults (≥65 years of age) with an objective diagnosis of symptomatic orthostatic hypotension Intervention: The intervention will be 5g/day of salt supplementation in the form of encapsulated sodium chloride. Outcome measures: Primary outcome (Feasibility) recruitment and retention rates, adherence with intervention and study protocol, completeness of follow-up. Secondary Outcome (Efficacy): i) clinical: change in Orthostatic Hypotension Questionnaire score, modification/addition of OH pharmacotherapy, and falls events, ii) physiological measures of orthostasis: change in difference between supine and nadir systolic BP, standing BP at 1 minute, 24 hour mean BP measured by 24 hour ambulatory BP monitor, iii) cardiovascular biomarkers. Clinical Importance: A recommendation for long-term increases in salt intake may have adverse cardiovascular consequences, which necessitates the identification of the optimal range of salt intake associated with greatest reduction in falls risk and lowest cardiovascular risk. Our study will provide preliminary evidence of treatment effect and assess feasibility, to inform a definitive trial.

NCT ID: NCT06151496 Not yet recruiting - Outcome Clinical Trials

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.

NCT ID: NCT06151444 Not yet recruiting - Adverse Effect Clinical Trials

Intensive Versus Standard Treatment for Hypotension on Maternal Hemodynamics in Preeclamptic Patients

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics in preeclamptic patients following cesarean section.

NCT ID: NCT06138574 Not yet recruiting - Rhinoplasty Surgery Clinical Trials

Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study

Effects of Dex
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.

NCT ID: NCT06133842 Not yet recruiting - Clinical trials for Postoperative Delirium

CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State

CERBERUS
Start date: December 2023
Phase:
Study type: Observational

The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question[s] it aims to answer are: - Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? - How much does this optimal blood pressure level vary between patients? Participants will be asked to: - Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. - They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.

NCT ID: NCT06122935 Not yet recruiting - Clinical trials for Apheresis Related Hypotension

Evaluation of the Aurora Xi New Nomogram Software 2.0

Start date: November 14, 2023
Phase: N/A
Study type: Interventional

A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

NCT ID: NCT06102382 Not yet recruiting - Hypotension Clinical Trials

The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

Start date: December 10, 2023
Phase: N/A
Study type: Interventional

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

NCT ID: NCT06093893 Not yet recruiting - Clinical trials for Orthognathic Surgery

Hypotensive Anesthesia for Orthognathic Surgery

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes of three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events. The specific objectives of this study are to compare: 1. Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome) 2. Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss. 3. Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate. 4. Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time. 5. Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events. The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center. The anticipated 90 participants will be randomized into three groups: ) A Labetalol group in which the patients receive hypotensive anesthesia with the aid of labetalol, 2) A Nicardipine group in which the patients receive hypotensive anesthesia with the aid of nicardipine, and 3) A Dexmedetomidine group in which the patients receive hypotensive anesthesia with the aid of dexmedetomidine. The time it will take for each individual participant ranges from 1-3 months. This time includes the pre-operative visit, the surgical procedure, a 1-week post-operation visit, and then followed for 30 days post-operatively after which the patient's participation in the study will conclude.

NCT ID: NCT06076330 Not yet recruiting - Liver Cirrhosis Clinical Trials

Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.

NCT ID: NCT06028256 Not yet recruiting - Anesthesia Clinical Trials

Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.