CARDU-FAST: Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery

• Sponsor: Hospital San Carlos, Madrid (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05706857
• Collaborator: (none)
• Enrollment: 382
• Arms: 2
• Anticipated Duration (Months): 35.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease; Surgery; Anesthesia	Behavioral: Ultra Fast-track	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 382 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Double
• Primary Purpose: Health Services Research
• Official Title: Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
• Anticipated Study Start Date: Jan 22, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultra fast-track Patients are extubated in the operating room after the procedure	Behavioral: Ultra Fast-track; Patients are extubated in the operating room
Active Comparator: Conventional extubation Patients are extubated in the intensive unit care	Behavioral: Ultra Fast-track; Patients are extubated in the operating room

Outcome Measures

Primary Outcome Measures

1. Determine the effect of Ultra Fast-track [1 year]

   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

1. Procedural resources conpsumption [1 year]

   Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).

2. Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h. [1 year]

   Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.

3. Differences in major bleeding or life-threatening bleeding. [1 year]

   Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).

4. Differences in neurological complication [1 year]

   Comparison of the incidence of neurological complication after the procedure.

5. Differences in the incidence of acute myocardial infarction. [1 year]

   Comparison of the incidence of acute myocardial infarction after the procedure.

6. Differences in the incidence of heart reoperation [1 year]

   Comparison of the reoperation rate after the procedure.

7. Differences in the incidence of infections rate. [1 year]

   Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Pregnancy.

2. Emergent surgery or cardiorespiratory arrest.

3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.

4. Aortic arch procedures.

5. Procedures in which hypothermia < 28ºC of temperature is expected during the intervention.

6. Minor cardiac surgery procedures.

7. 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).

8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).

9. Active endocarditis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital San Carlos, Madrid

Investigators

• Principal Investigator: Lourdes Montero Cruces, Hospital San Carlos, Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lourdes Montero Cruces, Cardiovascular Surgeon, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT05706857
• Other Study ID Numbers: 22/720-EC_X
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Jan 31, 2023