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

Surgery Clinical Trial

— CARDU-FAST  

Official title:

Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706857
• Other study ID #: 22/720-EC_X
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Hospital San Carlos, Madrid
• Contact: Lourdes Montero Cruces
• Phone: 616622432
• Email: lourdes.montero[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cardiac Disease
• Heart Diseases
• Surgery

Intervention

Behavioral:
• Ultra Fast-track
Patients are extubated in the operating room

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Procedural resources conpsumption	Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).	1 year
Secondary	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.	1 year
Secondary	Differences in major bleeding or life-threatening bleeding.	Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).	1 year
Secondary	Differences in neurological complication	Comparison of the incidence of neurological complication after the procedure.	1 year
Secondary	Differences in the incidence of acute myocardial infarction.	Comparison of the incidence of acute myocardial infarction after the procedure.	1 year
Secondary	Differences in the incidence of heart reoperation	Comparison of the reoperation rate after the procedure.	1 year
Secondary	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.	1 year