Hemodynamic InstabilityNCT02365688
Hemodynamic Response During Goal Directed Fluid Therapy in the OR
A study testing Initial bolus pre-incision in people with Hemodynamic Instability, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Initial bolus pre-incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults ≥18 years booked for an open abdominal procedure
- American Society of Anaesthesiologists (ASA) Physical Status 1 - 3
- Expected duration of surgical procedure to be ≥ 2 hours
- Standard of care monitoring to include cardiac output
Who cannot join
- Open chest surgical procedure expected
- Cardiac arrhythmia such as atrial fibrillation.
- Right Ventricular Failure
- Aortic regurgitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Correlation of Multiple Invasive and Non-Invasive Hemodynamic Monitored Modalities to Support Goal Directed Fluid Therapy During Open Abdominal Surgery
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.
Read the detailed description
Electronic and annotated observation data to support an algorithm library
- Conditions
- Hemodynamic Instability
- Being tested
- Initial bolus pre-incision
- Keywords
- Open Abdominal Surgical Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial bolus pre-incisionProcedure or surgery
Measured hemodynamic response to pre-incision bolus
| Study group | Role | What they receive |
|---|---|---|
| Initial bolus pre-incision | Other | Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded Receives: Procedure: Initial bolus pre-incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Hemodynamic Response to Fluid Resuscitation
Physiological parameters compared before and after fluid bolus for fluid resuscitation.
Measured: Up to 6 hours but not to exceed duration of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Lack of consistent reference devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy E Miller, MB ChB, FRCA, Principal investigator, DUHS Department of Anestheiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365688
- Sponsor's protocol ID
- COVMOPR0436
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2014
- Last updated
- 18 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data collected for new algorithm development
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Multiple Invasive and Non-Invasive Hemodynamic Monitored Modalities to Support Goal Directed Fluid Therapy During Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02365688
- Acronym / sponsor ID
- COVMOPR0436
- Conditions
- Hemodynamic Instability
- Keywords
- Open Abdominal Surgical Procedure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of consistent reference devices
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 23 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.
Detailed description
Electronic and annotated observation data to support an algorithm library
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initial bolus pre-incision | Other | Procedure: Initial bolus pre-incisionInitial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years booked for an open abdominal procedure
- American Society of Anaesthesiologists (ASA) Physical Status 1 - 3
- Expected duration of surgical procedure to be ≥ 2 hours
- Standard of care monitoring to include cardiac output
Key exclusion criteria (4 listed)
- Open chest surgical procedure expected
- Cardiac arrhythmia such as atrial fibrillation.
- Right Ventricular Failure
- Aortic regurgitation
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 |
|---|---|---|
| Initial bolus pre-incisionMeasured hemodynamic response to pre-incision bolus | Procedure or surgery | Initial bolus pre-incision |
Primary outcome
Dynamic Hemodynamic Response to Fluid Resuscitation
Time frame: Up to 6 hours but not to exceed duration of surgical procedure
Physiological parameters compared before and after fluid bolus for fluid resuscitation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data collected for new algorithm development
Related trials for Hemodynamic Instability
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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.
Timothy E Miller, MB ChB, FRCA principal investigator
DUHS Department of Anestheiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial bolus pre-incision in people with Hemodynamic Instability, run by Medtronic - MITG at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Jul 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dynamic Hemodynamic Response to Fluid Resuscitation (time frame: Up to 6 hours but not to exceed duration of surgical procedure). 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 18 Jul 2017.