InotropyRESIPINCT03208023
RESIPI for Reducing Perioperative Major Adverse Cardiac Events
A study testing RESIPI Management Strategy in people with Inotropy and Fluid Management, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inotropy, Fluid Management, Cardiac Event
- What is being tested?
- RESIPI Management Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 3 Dec 2018
- 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
- Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
- Surgery type: Major Abdominal Oncologic Surgery
- Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days
Who cannot join
- Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
- Patients with Chronic Kidney Disease Stage IV or V
- Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
- No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
Read the detailed description
Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
- Conditions
- Inotropy, Fluid Management, Cardiac Event, Perioperative Cardiac Risk, Vascular Resistance, Hemodynamic Monitoring
- Being tested
- RESIPI Management Strategy, No intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESIPI Management StrategyProcedure or surgery
a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc).
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard intraoperative care- no interventions | Active comparator | Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions Receives: Other: No intervention |
| RESIPI | Experimental | Intraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical). Receives: Procedure: RESIPI Management Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-typer Natriuretic Peptide (BNP)
Change in BNP (>250 ng/ml)
Measured: Post Op day 1
Troponin
Change in troponin (>=0.04%)
Measured: Post Op day 1
Secondary outcomes (8)
All-cause mortality
Measured: 30 days post op
Major cardiac events
Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest)
Measured: 30 days post op
Hospital length of stay
Measured: Approximately 3-5 days
Readmission rate (Emergency room or hospital)
Measured: 30 days post operative
Return to operating room
Measured: 30 days post operative
Total hospital cost
Measured: 30 days post operative
Occurrence of significant medical events
Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180)
Measured: 30 days post operative
Days at home in first 30 days
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start9 Oct 2017
- Primary completion1 Nov 2018
- Study completion3 Dec 2018
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InotropyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cheetah Medical Inc.
- Responsible party
- Principal investigator, Matthew McEvoy, Vanderbilt University Medical Center
- Investigators
- Matthew D McEvoy, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208023
- Sponsor's protocol ID
- 170601
- Acronym
- RESIPI
- Status last verified
- Nov 2022
- First submitted
- 30 Jun 2017
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03208023
- Acronym / sponsor ID
- RESIPI / 170601
- Conditions
- Inotropy, Fluid Management, Cardiac Event, Perioperative Cardiac Risk, Vascular Resistance, Hemodynamic Monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Cheetah Medical Inc.
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 5 Jul 2017 (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.
This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
Detailed description
Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intraoperative care- no interventions | Active comparator | Other: No interventionStandard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions |
| RESIPI | Experimental | Procedure: RESIPI Management StrategyIntraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
- Surgery type: Major Abdominal Oncologic Surgery
- Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days
Key exclusion criteria (4 listed)
- Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
- Patients with Chronic Kidney Disease Stage IV or V
- Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
- No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30
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 |
|---|---|---|
| RESIPI Management Strategya structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc). | Procedure or surgery | RESIPI |
| No interventionNo intervention | Other | Standard intraoperative care- no interventions |
Primary outcome
B-typer Natriuretic Peptide (BNP)
Time frame: Post Op day 1
Change in BNP (>250 ng/ml)
Troponin
Time frame: Post Op day 1
Change in troponin (>=0.04%)
8 secondary outcomes
All-cause mortality
Time frame: 30 days post op
Major cardiac events
Time frame: 30 days post op
Hospital length of stay
Time frame: Approximately 3-5 days
Readmission rate (Emergency room or hospital)
Time frame: 30 days post operative
Return to operating room
Time frame: 30 days post operative
Total hospital cost
Time frame: 30 days post operative
Occurrence of significant medical events
Time frame: 30 days post operative
Days at home in first 30 days
Time frame: 30 days post operative
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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.
Matthew D McEvoy, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESIPI Management Strategy in people with Inotropy and Fluid Management, run by Vanderbilt University Medical Center 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 3 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 17 Nov 2022. 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?
The study was stopped early (reason given: Futility). Results are not available in the source record.
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?
B-typer Natriuretic Peptide (BNP) (time frame: Post Op day 1). The study lists 2 primary outcomes in all. 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 17 Nov 2022.