Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04958668
Other study ID # 20-1050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids. The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date August 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Valve reconstruction or valve replacement - Must be capable to giving written consent Exclusion Criteria: - Intolerance to volatile anaesthetics (e.g. malignant hyperthermia) - Severe obstructive pulmonary disease - Extended aortic arch or ascending aorta surgery - Age <18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Post-operative intensive care using volatile sedation
Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..

Locations

Country Name City State
Germany University Hospital Frankfurt Frankfurt Hessen

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to extubation Time from admission on ICU until awakening and Extubation. through study completion, an average of 2 days
Secondary Time to neurocognitive assessability Time from admission on ICU until awake and neurocognitive assessable. through study completion, an average of 2 days
Secondary Required setup time of the intensive care workplace Required setup time of the intensive care workplace to provide volatile or intravenous sedation. through study completion, up to 24 hours
Secondary Factor related to the course of intensive care: blood loss Measured Postoperative Blood Loss through study completion, an average of 24 hours
Secondary Factor related to the course of intensive care: kidney injury Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria. through study completion, an average of 24 hours
Secondary Factor related to the course of intensive care: acid-base balance Measured serum lactate levels and hypercapnia through study completion, an average of 24 hours
Secondary Factor related to the course of intensive care: lung function parameters Required inspiratory oxygen fraction through study completion, an average of 24 hours
Secondary Factor related to the course of intensive care:cardiovascular medication Required dosage of adrenaline, noradrenaline, vasopressin or milrinone through study completion, an average of 24 hours
Secondary Factors related to the course of operative procedure time of the intraoperative procedure including the heart-lung-machine through study completion, up to 24 hours
Secondary Intra-hospital mortality Intra-hospital mortality - Safety outcome through study completion, an average of 7 days
Secondary Liver failure Intra-hospital liver failure - Safety outcome through study completion, an average of 7 days
Secondary postoperative nausea and vomiting Detection of postoperative nausea and vomiting through study completion, up to 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT05079672 - Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery Phase 4
Completed NCT03347851 - Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Completed NCT04328090 - Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship N/A
Recruiting NCT04359030 - Freestyle-Perimount Calcification Comparison
Completed NCT04598360 - Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine) N/A
Not yet recruiting NCT04118621 - Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
Recruiting NCT06387446 - Allogeneic Valve Transplantation N/A
Recruiting NCT04843072 - Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis N/A
Completed NCT05804500 - RecoveryPlus Telerehab Platform Pilot Study N/A
Recruiting NCT03885180 - Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy N/A
Completed NCT06154018 - Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass. N/A
Recruiting NCT06041308 - Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
Suspended NCT01571791 - Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery Phase 2
Completed NCT06261788 - Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter N/A
Completed NCT06079008 - The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Active, not recruiting NCT03661398 - Caisson Transcatheter Mitral Valve Replacement (TMVR) N/A
Recruiting NCT03595423 - SPAnish Aortic VALVE Multicentric Study