Hemodynamic InstabilityVOLTANCT04089098
VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
An observational study of Hemodynamic Instability and Shock, run by University of Leipzig at 1 site in Germany.
Trial summary
This prospective observational study will include critically ill patients with hemodynamic compromise. It will compare passive leg raising and a mini volume challenge (MVC) carried out on every patient sequentially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Shock, Septic Shock
- What is being tested?
- passive leg raising versus mini volume challenge
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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: critically ill adult medical patients with signs of hemodynamic instability
Who may be able to join
- mean arterial pressure <65 mm Hg and/or
- blood lactate >2 mmol/l and/or
- mottling or capillary refill >3 seconds and/or
- oliguria and
- critical care decision for testing fluid responsiveness
Who cannot join
- cardiopulmonary resuscitation
- uncontrolled bleeding
- irreversible brain damage
- pregnancy and lactation
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)
This prospective observational study will include critically ill patients with hemodynamic compromise. It will compare passive leg raising and a mini volume challenge (MVC) carried out on every patient sequentially. The endogenous release of stress hormones will also be assayed in order to investigate their modifying effect on the hemodynamic reaction of the participants. The effect of fluid resuscitation on renal perfusion will also be assessed and the data compared with the release of cystatin C.
Read the detailed description
Fluids are administered either before starting with or during ongoing vasopressor treatment in critically ill patients with hemodynamic instability. The endogenous release of stress hormones, namely renin, vasopressin, norepinephrine and cortisol, may be variable in critically ill patients, which may have a modifying effect on the hemodynamic response. Passive leg raising (PLR), a validated, simple and dynamic test, is currently recommended for testing fluid responsiveness. The test might possibly be false negative under extreme dehydration or increased intra-abdominal pressure. This prospective observational study aims to compare PLR and MVC with 300 ml Ringer acetate solution administered as a bolus within 5 minutes in critically ill medical patients with a hemodynamic instability. MVC will be carried out in every participant following PLR. Blood samples will be collected immediately before PLR for measurement of renin, copeptin A, cortisol and norepinephrine in those patients not yet receiving a vasopressor. These biomarkers will be compared with the Magnitude of fluid responsiveness. Additionally, renal resistive index will be assessed with ultrasound immediately before PLR and 1 and 24 hours after fluid challenge and the data compared with Initial serum cystatin C in those patients who have not yet developed acute renal failure. Blood samples for measurement of angiopoietin-2, a marker of capillary leak, will be drawn immediately before PLR and the data will be correlated with the amount of fluid required for Initial resuscitation.
- Conditions
- Hemodynamic Instability, Shock, Septic Shock
- Being tested
- passive leg raising versus mini volume challenge
- Keywords
- fluid resuscitation, shock, volume challenge, passive leg raising, renal perfusion, fluid responsiveness
- Medical subject headings
- Shock, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raising versus mini volume challengeDiagnostic test
Blood samples will be collected and ultrasound evaluation of renal perfusion conducted in study participants immediately before conducting passive leg raising (PLR). PLR will then be carried out on study participants, followed by MVC. PLR- and/or MVC-responsive patients will receive a further 700 ml fluid immediately after the MVC. Renal perfusion will be further assessed 1 and 24 hours after the MVC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure under PLR vs. MVC
changes in mean arterial pressure with PLR vs. MVC
Measured: immediately at the end of the MVC
Secondary outcomes (4)
Hemodynamic changes with PLR vs. MVC
Changes in cardiac Output under PLR vs. MVC
Measured: immediately at the end of the MVC
fluid requirement and endogenous stress response
correlation between fluid requirement and the level of endogenous renin, copeptin A, cortisol and norepinephrine
Measured: at the end of the first 3 hours of fluid resuscitation
fluid administration versus renal perfusion
renal resistive index will be assessed 1 and 24 hours after the Initial fluid resuscitation
Measured: 1 and 24 hours after initial fluid resuscitation
fluid administration and capillary leak
Fluid resuscitation in the first 3 hours vs. initial serum angiopoietin-2
Measured: at the end of the first 3 hours of fluid resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirak Petros, MD, University of Leipzig
- Investigators
- Sirak Petros, MD, Study director, University Hospital of Leipzig, Medical ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089098
- Sponsor's protocol ID
- VOLTA-01
- Acronym
- VOLTA
- Status last verified
- Jun 2022
- First submitted
- 3 Sep 2019
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)
- ClinicalTrials.gov ID
- NCT04089098
- Acronym / sponsor ID
- VOLTA / VOLTA-01
- Conditions
- Hemodynamic Instability, Shock, Septic Shock
- Keywords
- fluid resuscitation, shock, volume challenge, passive leg raising, renal perfusion, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Sep 2019 (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 prospective observational study will include critically ill patients with hemodynamic compromise. It will compare passive leg raising and a mini volume challenge (MVC) carried out on every patient sequentially. The endogenous release of stress hormones will also be assayed in order to investigate their modifying effect on the hemodynamic reaction of the participants. The effect of fluid resuscitation on renal perfusion will also be assessed and the data compared with the release of cystatin C.
Detailed description
Fluids are administered either before starting with or during ongoing vasopressor treatment in critically ill patients with hemodynamic instability. The endogenous release of stress hormones, namely renin, vasopressin, norepinephrine and cortisol, may be variable in critically ill patients, which may have a modifying effect on the hemodynamic response. Passive leg raising (PLR), a validated, simple and dynamic test, is currently recommended for testing fluid responsiveness. The test might possibly be false negative under extreme dehydration or increased intra-abdominal pressure. This prospective observational study aims to compare PLR and MVC with 300 ml Ringer acetate solution administered as a bolus within 5 minutes in critically ill medical patients with a hemodynamic instability. MVC will be carried out in every participant following PLR. Blood samples will be collected immediately before PLR for measurement of renin, copeptin A, cortisol and norepinephrine in those patients not yet receiving a vasopressor. These biomarkers will be compared with the Magnitude of fluid responsiveness. Additionally, renal resistive index will be assessed with ultrasound immediately before PLR and 1 and 24 hours after fluid challenge and the data compared with Initial serum cystatin C in those patients who have not yet developed acute renal failure. Blood samples for measurement of angiopoietin-2, a marker of capillary leak, will be drawn immediately before PLR and the data will be correlated with the amount of fluid required for Initial resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill adult medical patients with signs of hemodynamic instability
Key inclusion criteria (5 listed)
- mean arterial pressure <65 mm Hg and/or
- blood lactate >2 mmol/l and/or
- mottling or capillary refill >3 seconds and/or
- oliguria and
- critical care decision for testing fluid responsiveness
Key exclusion criteria (5 listed)
- cardiopulmonary resuscitation
- uncontrolled bleeding
- irreversible brain damage
- pregnancy and lactation
- Age under 18 years
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 |
|---|---|---|
| passive leg raising versus mini volume challengeBlood samples will be collected and ultrasound evaluation of renal perfusion conducted in study participants immediately before conducting passive leg raising (PLR). PLR will then be carried out on study participants, followed by MVC. PLR- and/or MVC-responsive patients will receive a further 700 ml fluid immediately after the MVC. Renal perfusion will be further assessed 1 and 24 hours after the MVC. | Diagnostic test | – |
Primary outcome
Changes in blood pressure under PLR vs. MVC
Time frame: immediately at the end of the MVC
changes in mean arterial pressure with PLR vs. MVC
4 secondary outcomes
Hemodynamic changes with PLR vs. MVC
Time frame: immediately at the end of the MVC
fluid requirement and endogenous stress response
Time frame: at the end of the first 3 hours of fluid resuscitation
fluid administration versus renal perfusion
Time frame: 1 and 24 hours after initial fluid resuscitation
fluid administration and capillary leak
Time frame: at the end of the first 3 hours of fluid resuscitation
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 30 Jun 2022.
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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.
Sirak Petros, MD study director
University Hospital of Leipzig, Medical ICU
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 Hemodynamic Instability and Shock, run by University of Leipzig at 1 site in Germany.
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 5 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 30 Jun 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 Germany. 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?
Changes in blood pressure under PLR vs. MVC (time frame: immediately at the end of the MVC). 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 30 Jun 2022.