Back to resultsEvaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery (CARDU-FAST)
Primary Purpose
Cardiac Disease, Surgery, Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultra Fast-track
Sponsored by
About this trial
This is an interventional health services research trial for Cardiac Disease
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age. Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery. The patient's desire to participate in the clinical trial verified by signing the informed consent. Exclusion Criteria: Pregnancy. Emergent surgery or cardiorespiratory arrest. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support. Aortic arch procedures. Procedures in which hypothermia < 28ºC of temperature is expected during the intervention. Minor cardiac surgery procedures. Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting). Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation). Active endocarditis.
Sites / Locations
- Hospital Clínico San CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultra fast-track
Conventional extubation
Arm Description
Patients are extubated in the operating room after the procedure
Patients are extubated in the intensive unit care
Outcomes
Primary Outcome Measures
Determine the effect of Ultra Fast-track
Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.
Secondary Outcome Measures
Procedural resources conpsumption
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.
Differences in major bleeding or life-threatening bleeding.
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Differences in neurological complication
Comparison of the incidence of neurological complication after the procedure.
Differences in the incidence of acute myocardial infarction.
Comparison of the incidence of acute myocardial infarction after the procedure.
Differences in the incidence of heart reoperation
Comparison of the reoperation rate after the procedure.
Differences in the incidence of infections rate.
Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.
Full Information
NCT ID
NCT05706857
First Posted
January 20, 2023
Last Updated
September 30, 2023
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05706857
Brief Title
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery
Acronym
CARDU-FAST
Official Title
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.
Detailed Description
The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 382 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by December 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Surgery, Anesthesia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
Masking
InvestigatorOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
382 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultra fast-track
Arm Type
Experimental
Arm Description
Patients are extubated in the operating room after the procedure
Arm Title
Conventional extubation
Arm Type
Active Comparator
Arm Description
Patients are extubated in the intensive unit care
Intervention Type
Behavioral
Intervention Name(s)
Ultra Fast-track
Intervention Description
Patients are extubated in the operating room
Primary Outcome Measure Information:
Title
Determine the effect of Ultra Fast-track
Description
Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Procedural resources conpsumption
Description
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Time Frame
1 year
Title
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
Description
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.
Time Frame
1 year
Title
Differences in major bleeding or life-threatening bleeding.
Description
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Time Frame
1 year
Title
Differences in neurological complication
Description
Comparison of the incidence of neurological complication after the procedure.
Time Frame
1 year
Title
Differences in the incidence of acute myocardial infarction.
Description
Comparison of the incidence of acute myocardial infarction after the procedure.
Time Frame
1 year
Title
Differences in the incidence of heart reoperation
Description
Comparison of the reoperation rate after the procedure.
Time Frame
1 year
Title
Differences in the incidence of infections rate.
Description
Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age.
Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
The patient's desire to participate in the clinical trial verified by signing the informed consent.
Exclusion Criteria:
Pregnancy.
Emergent surgery or cardiorespiratory arrest.
Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
Aortic arch procedures.
Procedures in which hypothermia < 28ºC of temperature is expected during the intervention.
Minor cardiac surgery procedures.
Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
Active endocarditis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lourdes Montero Cruces
Phone
616622432
Email
lourdes.montero@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourdes Montero Cruces
Organizational Affiliation
Hospital San Carlos, Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes Montero Cruces
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery
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