Clinical trials: Post-operative Cardiac Surgery
Critical Illness
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care.
- Trial name
- DELIOS 02 (NCT01233271)
- Testing
- Space TGC
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- B. Braun Melsungen AG
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG)…
- Trial name
- NCT00464763
- Testing
- Dexmedetomidine
- Where
- 11 sites in United States
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Ventilator Induced Diaphragm Dysfunction
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT04899856)
- Testing
- TransAeris
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Respiratory Failure, Respiratory Arrest
Postoperative Respiratory Abnormalities
The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities.
- Conditions
- Respiratory Failure, Respiratory Arrest, Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- AI-ARF (NCT04079829)
- Testing
- Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
AKI - Acute Kidney Injury, Cardiac Surgery
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device.
- Conditions
- AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability
- Trial name
- NCT07022314
- Testing
- FIZE kUO®
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- FIZE Medical ltd
Post Operative Pain, Midline Sternotomy Incision
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
- Trial name
- POPS (NCT03750357)
- Testing
- Primary Relief v 2.0
- Where
- India
- Volunteers
- 60 people
- Sponsor
- DyAnsys, Inc.
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Esophageal Cancer, Esophagus Cancer
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Trial name
- ESPY (NCT06097078)
- Testing
- Eso-SPONGE®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Aesculap AG
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization
- Trial name
- NCT00157716
- Testing
- (MC-1) Pyridoxal-5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 900 people
- Sponsor
- Medicure
Heart; Dysfunction Postoperative, Cardiac Surgery
VolulyteTM in Cardiac Surgery
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Trial name
- NCT01553617
- Testing
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
- Where
- 5 sites in Canada
- Volunteers
- 133 people
- Sponsor
- Fresenius Kabi
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC
Safety, Tolerance
Evaluation of COVA™+ CARD in Adult Cardiac Surgery
The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery.
- Trial name
- NCT03140098
- Testing
- cardiac surgery requiring a collagen membrane COVA™+
- Sponsor
- Biom'Up France SAS
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium 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.
Heart; Dysfunction Postoperative, Cardiac Surgery
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor.
- Trial name
- NCT01289470
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Nonin Medical, Inc
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
Post-Operative Atrial Fibrillation
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of…
- Trial name
- NCT03779841
- Testing
- AGN-151607
- Where
- 32 sites in United States, Austria and 7 more
- Volunteers
- 323 people
- Sponsor
- AbbVie