Clinical trials: Cardiac Surgery Subjects
Cardiac Surgery Subjects
PuO2 in RenalGuard Pilot Study
The PuO2 in RenalGuard (PURE) study is planned as a single center, randomized controlled pilot study comparing renal oxygenation during cardiac surgery with cardiopulmonary bypass (CPB) with or without balanced forced diuresis…
- Trial name
- PURE (NCT06886191)
- Testing
- RenalGuard Therapy
- Volunteers
- 30 people
- Sponsor
- Sahlgrenska University Hospital
Surgical Wound Infection
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized…
- Trial name
- NCT00203541
- Testing
- TELFA™ A.M.D. Island dressing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Tyco Healthcare Group
Coronary Artery Bypass Graft (CABG), Cardiac Surgery Subjects
Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery
The goal of this clinical trial is to examine the effects of sensory and cognitive stimulation on physiological, psychological, and functional recovery in adult patients after cardiac surgery who are treated in the intensive care…
- Conditions
- Coronary Artery Bypass Graft (CABG), Cardiac Surgery Subjects, Postoperative Care
- Trial name
- MICU-CARE (NCT07116941)
- Testing
- Cognitive Exercises, Auditory Stimulation, Multisensory Stimulation
- Where
- Turkey (Türkiye)
- Volunteers
- 124 people
- Sponsor
- Abant Izzet Baysal University
AKI - Acute Kidney Injury
Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine
This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery…
- Trial name
- EASE-AKI (NCT07661940)
- Testing
- SP16-3M
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Type 2 Diabetes Mellitus, Cardiovascular Disease
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels.
- Trial name
- MAPSS (NCT01765270)
- Testing
- Saxagliptin
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- Duke University
Cardiovascular Disease
Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery
- Trial name
- NCT00038454
- Testing
- Hemolink (hemoglobin raffimer IV solution)
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 180 people
- Sponsor
- Hemosol
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Cardiac Surgery Subjects
Objective Measurement of the Mechanical Pain Threshold With an Algometer for Predicting Intraoperative Opioid Consumption in Patients Who Will be Operate by Thoracotomy and Sternotomy in Cardiac Surgery
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids. The objective of the study is to try to predict a patient's analgesic needs based on their objectively…
- Trial name
- NCT07513974
- Testing
- Measure of the minimal pain threshold with an algometer
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Université Libre de Bruxelles
Sternal Wound Infection, Mediastinitis
Rapid Sternal Closure System (TALON)
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function.
- Trial name
- TALON (NCT00638014)
- Testing
- Rapid Sternal Closure System, Conventional wire closure
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Duke University
Postoperative Pain
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs.
- Trial name
- NCT06271265
- Testing
- EXPAREL, bupivacaine
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Acute Kidney Injury
A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- NCT02610283
- Testing
- QPI-1002
- Where
- 36 sites in United States, Canada and 1 more
- Volunteers
- 341 people
- Sponsor
- Quark Pharmaceuticals
Acute Kidney Injury
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
Subjects entering the study will have undergone cardiac surgery. Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study.
- Trial name
- ACT-AKI (NCT01602328)
- Testing
- AC607, Vehicle Only
- Where
- 31 sites in United States, Canada
- Volunteers
- 156 people
- Sponsor
- AlloCure Inc.
Post-Operative Complications in Cardiac Surgery
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: Patient reported outcomes (PRO), using the EQ-5D questionnaire Clinical outcomes
- Trial name
- NCT06092970
- Testing
- RBT-1
- Where
- 39 sites in United States, Canada
- Volunteers
- 353 people
- Sponsor
- Renibus Therapeutics, Inc.
Reversal of Neuromuscular Blockade
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of…
- Trial name
- NCT03346057
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg
- Where
- 30 sites in United States, Austria and 2 more
- Volunteers
- 344 people
- Sponsor
- Merck Sharp & Dohme LLC
Heart Diseases, Postoperative Complications
A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass
The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery.
- Trial name
- NCT00271167
- Testing
- INO-1001
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 162 people
- Sponsor
- Inotek Pharmaceuticals Corporation
Subjects Undergoing Cardiac or Major Surgery Where TEE is Used as a Matter of Routine
Use of Transesophageal Echocardiography to Measure Intraoperative Renal Resistive Index and Predict Acute Renal Injury
The investigators hypothesize that transesophageal echocardiography is a valid method to obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a correlation between abnormal TEE resistive index…
- Trial name
- NCT01547065
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Rutgers, The State University of New Jersey
Atrial Fibrillation, Postoperative
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein).
- Trial name
- AMIOMEND (NCT06730828)
- Testing
- The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Helios Cardio Inc.
Acute Kidney Injury (AKI)
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
- Trial name
- NCT04829916
- Testing
- RMC-035
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Guard Therapeutics AB
Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require…
- Trial name
- FCAD02 (NCT00838383)
- Testing
- sitaxsentan (Thelin)
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Pfizer