Cardiac SurgeryPhase 2NCT01681758
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
A Phase 2 study testing IV fluid according to PPV in people with Cardiac Surgery, run by Austin Health at 1 site in Australia.
Trial summary
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- IV fluid according to PPV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- immediately after ICU admission after cardiac surgery
- mandatory mechanical ventilation -
Who cannot join
- Pressure support ventilation
- ECMO
- Intra-aortic balloon counterpulsation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery
Read the detailed description
- The investigators will study patients after cardiac surgery
- The investigators will collect data on standard care in pre-intervention population
- The investigators will collect demographic and clinical data
- The investigators will collect biochemical data in the first 24 hours after surgery
- The investigators will collect biochemical, physiological and clinical outcome data
- The investigators will compare the standard care and intervention period data
- Conditions
- Cardiac Surgery
- Being tested
- IV fluid according to PPV, fluids according to standard care
- Keywords
- cardiac surgery, Pulse pressure variation, intravenous fluids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fluid according to PPVOther
intravenous fluids
fluids according to standard careOther
| Study group | Role | What they receive |
|---|---|---|
| PPV | Active comparator | use PPV to guide fluid therapy Receives: Other: IV fluid according to PPV |
| standard care | Placebo comparator | fluids according to standard care Receives: Other: fluids according to standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amount of fluid given in the first 24 hours after surgery
all intravenous fluid administered
Measured: 24 hours
Secondary outcomes (1)
Physiological outcome
Blood lactate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rinaldo Bellomo, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681758
- Sponsor's protocol ID
- AICU2012-007
- Status last verified
- Jul 2013
- First submitted
- 6 Sep 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2014.07.032. Epub 2014 Aug 7.
PubMed 25220528
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01681758
- Acronym / sponsor ID
- AICU2012-007
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, Pulse pressure variation, intravenous fluids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Sep 2012 (estimated)
- 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.
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery
Detailed description
- The investigators will study patients after cardiac surgery
- The investigators will collect data on standard care in pre-intervention population
- The investigators will collect demographic and clinical data
- The investigators will collect biochemical data in the first 24 hours after surgery
- The investigators will collect biochemical, physiological and clinical outcome data
- The investigators will compare the standard care and intervention period data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPV | Active comparator | Other: IV fluid according to PPVuse PPV to guide fluid therapy |
| standard care | Placebo comparator | Other: fluids according to standard carefluids according to standard care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- immediately after ICU admission after cardiac surgery
- mandatory mechanical ventilation -
Key exclusion criteria (3 listed)
- Pressure support ventilation
- ECMO
- Intra-aortic balloon counterpulsation
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 |
|---|---|---|
| IV fluid according to PPVintravenous fluids | Other | PPV |
| fluids according to standard care | Other | standard care |
Primary outcome
Mean amount of fluid given in the first 24 hours after surgery
Time frame: 24 hours
all intravenous fluid administered
1 secondary outcome
Physiological outcome
Time frame: 24 hours
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 11 Jul 2013.
- Derived from this study: PubMed 25220528Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2014.07.032. Epub 2014 Aug 7.
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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?
A Phase 2 study testing IV fluid according to PPV in people with Cardiac Surgery, run by Austin Health at 1 site in Australia.
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 2 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 11 Jul 2013. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean amount of fluid given in the first 24 hours after surgery (time frame: 24 hours). 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 NCT01681758, 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 11 Jul 2013.