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VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)

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ClinicalTrials.gov Identifier: NCT04089098
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sirak Petros, MD, University of Leipzig

Brief 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. 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.

Condition or disease Intervention/treatment
Hemodynamic Instability Shock Septic Shock Diagnostic Test: passive leg raising versus mini volume challenge

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 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. 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. 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.

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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterizing VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Intervention Details:
  • Diagnostic Test: passive leg raising versus mini volume challenge
    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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hemodynamic changes with PLR vs. MVC [ Time Frame: immediately at the end of the MVC ]
    Changes in cardiac Output under PLR vs. MVC

  2. fluid requirement and endogenous stress response [ Time Frame: at the end of the first 3 hours of fluid resuscitation ]
    correlation between fluid requirement and the level of endogenous renin, copeptin A, cortisol and norepinephrine

  3. fluid administration versus renal perfusion [ Time Frame: 1 and 24 hours after initial fluid resuscitation ]
    renal resistive index will be assessed 1 and 24 hours after the Initial fluid resuscitation

  4. fluid administration and capillary leak [ Time Frame: at the end of the first 3 hours of fluid resuscitation ]
    Fluid resuscitation in the first 3 hours vs. initial serum angiopoietin-2


Biospecimen Retention:   Samples Without DNA
norepinephrine renin copeptin A cortisol angiopoietin-2 cystatin C


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
critically ill adult medical patients with signs of hemodynamic instability
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cardiopulmonary resuscitation
  • uncontrolled bleeding
  • irreversible brain damage
  • pregnancy and lactation
  • Age under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089098


Contacts
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Contact: Sirak Petros, MD 3419712700 ext ++49 sirak.petros@medizin.uni-leipzig.de
Contact: Lorenz Weidhase, MD 3419712480 ext ++49 lorenz.wiedhase@medizin.uni-leipzig.de

Locations
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Germany
University Hospital of Leipzig Recruiting
Leipzig, Saxony, Germany, D-04103
Contact: Sirak Petros, MD    3419712700 ext ++49    sirak.petros@medizin.uni-leipzig.de   
Contact: Lorenz Weidhase, MD    3419712480 ext ++49    lorenz.weidhase@medizin.uni-leipzig.de   
Sub-Investigator: Kevin Kunz, MD         
Sub-Investigator: Frank Seidel, MD         
Sponsors and Collaborators
University of Leipzig
Investigators
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Study Director: Sirak Petros, MD University Hospital of Leipzig, Medical ICU

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Responsible Party: Sirak Petros, MD, Professor, University of Leipzig
ClinicalTrials.gov Identifier: NCT04089098     History of Changes
Other Study ID Numbers: VOLTA-01
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sirak Petros, MD, University of Leipzig:
fluid resuscitation
shock
volume challenge
passive leg raising
renal perfusion
fluid responsiveness
Additional relevant MeSH terms:
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Shock
Pathologic Processes
Vasoconstrictor Agents