Clinical trial NCT04089098: VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Official title: Characterizing VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Shock
Septic Shock
Keywords: fluid resuscitation
shock
volume challenge
passive leg raising
renal perfusion
fluid responsiveness
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill adult medical patients with signs of hemodynamic instability

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in blood pressure under PLR vs. MVC
timeFrame: immediately at the end of the MVC
Secondary outcomes:
measure: Hemodynamic changes with PLR vs. MVC
timeFrame: immediately at the end of the MVC
measure: fluid requirement and endogenous stress response
timeFrame: at the end of the first 3 hours of fluid resuscitation
measure: fluid administration versus renal perfusion
timeFrame: 1 and 24 hours after initial fluid resuscitation
measure: fluid administration and capillary leak
timeFrame: at the end of the first 3 hours of fluid resuscitation
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital of Leipzig
state: Saxony
Study officials:
affiliation: University Hospital of Leipzig, Medical ICU
name: Sirak Petros, MD
role: STUDY_DIRECTOR
References: