Cardiac DiseaseCARDU-FASTNCT05706857
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery
A study testing Ultra Fast-track in people with Cardiac Disease and Surgery, run by Hospital San Carlos, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Surgery, Anesthesia
- What is being tested?
- Ultra Fast-track
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2023to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Disease, Surgery, Anesthesia
- Being tested
- Ultra Fast-track
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Fast-trackBehavioural
Patients are extubated in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Ultra fast-track | Experimental | Patients are extubated in the operating room after the procedure Receives: Behavioral: Ultra Fast-track |
| Conventional extubation | Active comparator | Patients are extubated in the intensive unit care Receives: Behavioral: Ultra Fast-track |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Procedural resources conpsumption
Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).
Measured: 1 year
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.
Measured: 1 year
Differences in major bleeding or life-threatening bleeding.
Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).
Measured: 1 year
Differences in neurological complication
Comparison of the incidence of neurological complication after the procedure.
Measured: 1 year
Differences in the incidence of acute myocardial infarction.
Comparison of the incidence of acute myocardial infarction after the procedure.
Measured: 1 year
Differences in the incidence of heart reoperation
Comparison of the reoperation rate after the procedure.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start22 Jan 2023
- Primary completion30 Jan 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes Montero Cruces, Hospital San Carlos, Madrid
- Investigators
- Lourdes Montero Cruces, Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706857
- Sponsor's protocol ID
- 22/720-EC_X
- Acronym
- CARDU-FAST
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cruces LM, Alcazar MC, Sial RLB, Vizcayno ML, Martin RS, Camargo DP, Carnicer JC, Mercadal LA, Morenza AA, Lacruz FR, Fernandez PC, Molano MAG, Torron JMM, Chavez MBS, Castellanos LCM. Evaluation of clinical impact of ultra fast-track versus conventional extubation in patients undergoing nonemergency cardiac surgery: 'CARDU-FAST': A randomised clinical trial. Eur J Anaesthesiol. 2026 Apr 28. doi: 10.1097/EJA.0000000000002400. Online ahead of print.
PubMed 42046539
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
- ClinicalTrials.gov ID
- NCT05706857
- Acronym / sponsor ID
- CARDU-FAST / 22/720-EC_X
- Conditions
- Cardiac Disease, Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
| Arm | Type | Receives |
|---|---|---|
| Ultra fast-track | Experimental | Behavioral: Ultra Fast-trackPatients are extubated in the operating room after the procedure |
| Conventional extubation | Active comparator | Behavioral: Ultra Fast-trackPatients are extubated in the intensive unit care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra Fast-trackPatients are extubated in the operating room | Behavioural | Conventional extubation, Ultra fast-track |
Primary outcome
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.
7 secondary outcomes
Procedural resources conpsumption
Time frame: 1 year
Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
Time frame: 1 year
Differences in major bleeding or life-threatening bleeding.
Time frame: 1 year
Differences in neurological complication
Time frame: 1 year
Differences in the incidence of acute myocardial infarction.
Time frame: 1 year
Differences in the incidence of heart reoperation
Time frame: 1 year
Differences in the incidence of infections rate.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 42046539Cruces LM, Alcazar MC, Sial RLB, Vizcayno ML, Martin RS, Camargo DP, Carnicer JC, Mercadal LA, Morenza AA, Lacruz FR, Fernandez PC, Molano MAG, Torron JMM, Chavez MBS, Castellanos LCM. Evaluation of clinical impact of ultra fast-track versus conventional extubation in patients undergoing nonemergency cardiac surgery: 'CARDU-FAST': A randomised clinical trial. Eur J Anaesthesiol. 2026 Apr 28. doi: 10.1097/EJA.0000000000002400. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes Montero Cruces principal investigator
Hospital San Carlos, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Fast-track in people with Cardiac Disease and Surgery, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of Ultra Fast-track (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.