VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility

NCT04089098 | Completed

• 1 other identifier: VOLTA-01
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Shock; Septic Shock

Keywords

fluid resuscitation; shock; volume challenge; passive leg raising; renal perfusion; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hemodynamic changes with PLR vs. MVC

  immediately at the end of the MVC

• fluid requirement and endogenous stress response

  at the end of the first 3 hours of fluid resuscitation

• fluid administration versus renal perfusion

  1 and 24 hours after initial fluid resuscitation

• fluid administration and capillary leak

  at the end of the first 3 hours of fluid resuscitation

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill adult medical patients with signs of hemodynamic instability

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

norepinephrine renin copeptin A cortisol angiopoietin-2 cystatin C

MeSH Terms

Conditions

Shock; Shock, Septic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Sirak Petros, MD

  University Hospital of Leipzig, Medical ICU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 13, 2019
• Study Start: September 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

DE (1)