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

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.

Study Overview

• Status: Completed
• Conditions: Shock; Septic Shock; Hemodynamic Instability
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, D-04103
      • University Hospital Of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

critically ill adult medical patients with signs of hemodynamic instability

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure under PLR vs. MVC	changes in mean arterial pressure with PLR vs. MVC	immediately at the end of the MVC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic changes with PLR vs. MVC	Changes in cardiac Output under PLR vs. MVC	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	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	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	at the end of the first 3 hours of fluid resuscitation

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Study Director: Sirak Petros, MD, University Hospital of Leipzig, Medical ICU

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): July 31, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (ACTUAL): September 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: shock; fluid resuscitation; fluid responsiveness; renal perfusion; passive leg raising; volume challenge
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: VOLTA-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No