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Completed

NCT Number: NCT04089098

VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

passive leg raising versus mini volume challenge

Diagnostic 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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: VOLTA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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