Cardiac SurgeryNCT07009730
Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass
An observational study of Cardiac Surgery and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
The aim of this prospective, randomized study was to compare clinical outcomes of Pulsatile and non-pulsatile flow during Cardiopulmonary Bypass. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- Bypassing Agents
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteNepal
- Study dates
- 23 Jul 2019to 23 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Patients undergoing Atrial Septal Defect closure and mitral Valve replacement
Who may be able to join
- patients undergoing Atrial Septal Defect closure and Mitral Valve replacement
Who cannot join
- • Moderate and severe LVEF
- • Patient with bleeding dysfunction;AKI ;deranged liver dysfunction\
- • Patient/Surrogate decision maker not giving written informed consent
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Tribhuvan University Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal
Kathmandu, 44600
About this study
The aim of this prospective, randomized study was to compare clinical outcomes of Pulsatile and non-pulsatile flow during Cardiopulmonary Bypass.
- Being tested
- Bypassing Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bypassing AgentsProcedure or surgery
Cardiopulmonary bypass surgery, pulsatile flow
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary bypass, pulsatile flow | Not described Receives: Procedure: Bypassing Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay
Measured in days from ICU admission to ICU discharge
Measured: 12 months
Secondary outcomes (1)
Duration of Cardiopulmonary Bypass (CPB)
Measured in minutes from initiation to termination of bypass
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start23 Jul 2019
- Primary completion22 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishwor Thapaliya, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009730
- Sponsor's protocol ID
- 20.7.2017
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07009730
- Acronym / sponsor ID
- 20.7.2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 8 Jun 2025 (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.
The aim of this prospective, randomized study was to compare clinical outcomes of Pulsatile and non-pulsatile flow during Cardiopulmonary Bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary bypass, pulsatile flow | – | Procedure: Bypassing Agents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients undergoing Atrial Septal Defect closure and mitral Valve replacement
Key inclusion criteria (1 listed)
- patients undergoing Atrial Septal Defect closure and Mitral Valve replacement
Key exclusion criteria (3 listed)
- • Moderate and severe LVEF
- • Patient with bleeding dysfunction;AKI ;deranged liver dysfunction\
- • Patient/Surrogate decision maker not giving written informed consent
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 |
|---|---|---|
| Bypassing AgentsCardiopulmonary bypass surgery, pulsatile flow | Procedure or surgery | Cardiopulmonary bypass, pulsatile flow |
Primary outcome
ICU Length of Stay
Time frame: 12 months
Measured in days from ICU admission to ICU discharge
1 secondary outcome
Duration of Cardiopulmonary Bypass (CPB)
Time frame: 12 months
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 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 1 inclusion and 3 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 8 Jun 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 Nepal. 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?
ICU Length of Stay (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2025.