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

NCT05706857 | Completed DMC

• 1 other identifier: 22/720-EC_X
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Procedural resources conpsumption

  1 year

• Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.

  1 year

• Differences in major bleeding or life-threatening bleeding.

  1 year

• Differences in neurological complication

  1 year

• Differences in the incidence of acute myocardial infarction.

  1 year

Study Arms (2)

Ultra fast-track

EXPERIMENTAL

Patients are extubated in the operating room after the procedure

Behavioral: Ultra Fast-track

Conventional extubation

ACTIVE COMPARATOR

Patients are extubated in the intensive unit care

Behavioral: Ultra Fast-track

Interventions

Ultra Fast-track BEHAVIORAL

Patients are extubated in the operating room

Conventional extubation; Ultra fast-track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Lourdes Montero Cruces

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon

Model Details: Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: January 22, 2023
• Primary Completion: January 30, 2025
• Study Completion: March 11, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-09

Locations

ES (1)