ShockVOLUMENCT03190408
Variation in Fluids Administered in Shock
An observational study of Shock, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Fluids
- How many people
- 1,639 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Feb 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with shock
Who may be able to join
- Age ≥ 18 years admitted to the participating hospital.
- Patients in the emergency department, intensive care unit, PACU, or any hospital floor. For patients not in the ICU, there must be plans to transfer to an intensive care unit when an ICU bed is available for patient.
- Patients with shock as defined by:
- Need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep MAP > 65 mmHg Or
- Systolic BP < 90 mmHg
Who cannot join
- Patients previously enrolled into this study.
- Patients who were in the operating room at time of shock and fluid bolus.
- Patients admitted to an ICU after cardiac surgery Patients with primarily cardiogenic shock as etiology for their shock
- Patients transferred from another hospital or emergency room to the study hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock
To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.
- Conditions
- Shock
- Being tested
- Fluids
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidsOther
Fluids Administered in Shock
| Study group | Role | What they receive |
|---|---|---|
| Shock | Not described Receives: Other: Fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method used to guide volume resuscitation
Characterize the method used to guide volume resuscitation and vasopressor use in patients with shock
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Sep 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies 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
- Prospective
- Enrolment
- 1,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190408
- Sponsor's protocol ID
- 2017-7860
- Acronym
- VOLUME
- Status last verified
- Jul 2020
- First submitted
- 14 Jun 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock
- ClinicalTrials.gov ID
- NCT03190408
- Acronym / sponsor ID
- VOLUME / 2017-7860
- Conditions
- Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,639 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 16 Jun 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.
To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock | – | Other: Fluids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with shock
Key inclusion criteria (5 listed)
- Age ≥ 18 years admitted to the participating hospital.
- Patients in the emergency department, intensive care unit, PACU, or any hospital floor. For patients not in the ICU, there must be plans to transfer to an intensive care unit when an ICU bed is available for patient.
- Patients with shock as defined by:
- Need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep MAP > 65 mmHg Or
- Systolic BP < 90 mmHg
Key exclusion criteria (4 listed)
- Patients previously enrolled into this study.
- Patients who were in the operating room at time of shock and fluid bolus.
- Patients admitted to an ICU after cardiac surgery Patients with primarily cardiogenic shock as etiology for their shock
- Patients transferred from another hospital or emergency room to the study hospital.
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 |
|---|---|---|
| FluidsFluids Administered in Shock | Other | Shock |
Primary outcome
Method used to guide volume resuscitation
Time frame: 7 days
Characterize the method used to guide volume resuscitation and vasopressor use in patients with shock
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 23 Jul 2020.
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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 Shock, run by Montefiore 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 5 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: finished, as of the sponsor's last update on 23 Jul 2020. 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 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?
Method used to guide volume resuscitation (time frame: 7 days). 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 23 Jul 2020.