Clinical trials: High Risk Surgery
Moderate to High-risk Noncardiac Surgery
SMART TRENDS Study
A multicenter, interventional, feasibility comparison with historical controls
- Trial name
- NCT05957406
- Testing
- Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
- Where
- 8 sites in United States
- Volunteers
- 296 people
- Sponsor
- Becton, Dickinson and Company
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
On-pump Cardiac Surgery, High Risk for Bleeding
COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding.
- Conditions
- On-pump Cardiac Surgery, High Risk for Bleeding, Autotransfusion
- Trial name
- COLTRANE (NCT06425614)
- Testing
- Autotransfusion
- Where
- 10 sites in France
- Volunteers
- 570 people
- Sponsor
- University Hospital, Bordeaux
Thoracic Surgery, Atrial Fibrillation in High Risk Patients
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting >30 seconds) or clinically significant POAF is…
- Trial name
- NCT02750319
- Testing
- Amiodarone, N-Acetylcysteine
- Where
- 9 sites in United States
- Volunteers
- 184 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Blood Pressure, Dexmedetomidine
Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality.
- Conditions
- Blood Pressure, Dexmedetomidine, High-risk Patients, Abdominal Surgery
- Trial name
- NCT03933306
- Testing
- Dexmedetomidine, Goal-directed blood pressure management, Routine blood pressure management
- Where
- China
- Volunteers
- 496 people
- Sponsor
- Peking University First Hospital
Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks
Transfusion Reduction in High-Bleeding-Risk Cardiac Surgery With Desmopressin
Rationale Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by…
- Conditions
- Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks, Planned Elective Cardiac Surgery Using CPB
- Trial name
- REDES-BLEED (NCT07012837)
- Testing
- Desmopresin
- Where
- Saudi Arabia
- Volunteers
- 112 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Elective Surgery, High Risk
General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery
The general decolonization of the human body surface by industrial antiseptic agents, before elective surgery is recommended by the World Health Organization (WHO).
- Conditions
- Elective Surgery, High Risk, Prevention of Surgical Site Infections, Randomized-controlled Trial
- Trial name
- BALGDEC (NCT05647252)
- Testing
- Whole Body and nasal decolonization with octenidin (Octenisan Set), Questionnaire for study participants immediately after the decolonization
- Where
- 2 sites in Switzerland
- Volunteers
- 1,086 people
- Sponsor
- Balgrist University Hospital
Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors
Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to…
- Trial name
- NCT06772428
- Testing
- Nano-crystalline Megestrol Acetate Oral Suspension, standard treatment
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
High-risk Lung Resection Surgery
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
High-risk patients scheduled for lung resection surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT).
- Trial name
- AEGIS (NCT06156943)
- Testing
- individualized goal-directed fluid therapy by Starling device, group managed by standard of care
- Where
- 10 sites in France
- Volunteers
- 722 people
- Sponsor
- Hospices Civils de Lyon
High Risk Non-cardiac Surgery, Death
Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery
Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the association between desaturations and…
- Conditions
- High Risk Non-cardiac Surgery, Death, Delirium, Kidney Injury
- Trial name
- NCT01838733
- Testing
- Observational study
- Where
- Canada
- Volunteers
- 146 people
- Sponsor
- University of Manitoba
High-risk Surgery
Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality
Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe.
- Trial name
- HeCoMo (NCT06355362)
- Volunteers
- 1,000 people
- Sponsor
- Kliniken Essen-Mitte
Moderate to High-risk Noncardiac Surgery
Hypotension Prediction Index (HPI) SMART-BP Trial
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
- Trial name
- NCT05105477
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- 11 sites in United States
- Volunteers
- 407 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgery, Cardiopulmonary Bypass
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding
- Trial name
- APACHE (NCT04804345)
- Testing
- standard of care
- Where
- 7 sites in France
- Volunteers
- 693 people
- Sponsor
- University Hospital, Bordeaux
Systemic Inflammatory Response Syndrome, Distributive Shock
Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intravenous waveform Analysis…
- Conditions
- Systemic Inflammatory Response Syndrome, Distributive Shock, Hypotension and Shock, Decompensated Congestive Heart Failure
- Trial name
- PIVA (NCT03407287)
- Testing
- Peripheral Intravenous Analysis (PIVA), Standard of care invasive vascular monitoring, Standard noninvasive vascular monitoring
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Vanderbilt University Medical Center
Acute High-risk Abdominal Surgery (AHA)
Early Mobilization Following Emergency Abdominal Surgery
Acute High-risk abdominal surgery (AHA) is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission.
- Trial name
- NCT03662932
- Testing
- Early intensive mobilization
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Morten Tange Kristensen PT, PhD
Goal-directed Fluid Therapy, Hemodynamics Instability
Multi-center Trial of Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring
Background: Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this hypothesis in a multi-center study.
- Conditions
- Goal-directed Fluid Therapy, Hemodynamics Instability, High-risk Surgery, Pulse-pressure Variation
- Trial name
- GDTPPV (NCT03128190)
- Testing
- Pulse pressure variation monitoring
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Moderated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two Hours
Individualized Perioperative Open Lung Ventilatory Strategy
The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and…
- Trial name
- iPROVE (NCT02158923)
- Testing
- Alveolar recruitment maneuver, Calculation of optimal PEEP, Postoperative CPAP
- Where
- 7 sites in United States, Argentina and 2 more
- Volunteers
- 920 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
High-risk, Non-cardiovascular Surgeries
Esmolol for Treatment of Perioperative Tachycardia
The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and…
- Trial name
- NCT01208402
- Testing
- Esmolol
- Where
- 3 sites in United States
- Volunteers
- 76 people
- Sponsor
- Duke University
Emergency High-risk Abdominal Surgery
Functional Performance Following Emergency High-risk Abdominal Surgery
Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission.
- Trial name
- NCT02124356
- Testing
- Evaluation of functional performance
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Hvidovre University Hospital
Hemodynamic Instability During Anesthesia, High Risk Surgery
Focused TTE for Hemodynamic Instable High Risk Patients
Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients.
- Trial name
- NCT01811914
- Testing
- intraoperative TTE
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Philipps University Marburg