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

March 13, 2025 updated by: Lourdes Montero Cruces, Hospital San Carlos, Madrid

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 612 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 September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
612

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the effect of Ultra Fast-track
Time Frame: 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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural resources conpsumption
Time Frame: 1 year
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
1 year
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
Time Frame: 1 year
Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.
1 year
Differences in major bleeding or life-threatening bleeding.
Time Frame: 1 year
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
1 year
Differences in neurological complication
Time Frame: 1 year
Comparison of the incidence of neurological complication after the procedure.
1 year
Differences in the incidence of acute myocardial infarction.
Time Frame: 1 year
Comparison of the incidence of acute myocardial infarction after the procedure.
1 year
Differences in the incidence of heart reoperation
Time Frame: 1 year
Comparison of the reoperation rate after the procedure.
1 year
Differences in the incidence of infections rate.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital San Carlos, Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lourdes Montero Cruces, Hospital San Carlos, Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/720-EC_X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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