University Hospital of Leipzig
Leipzig, Saxony, D-04103, Germany
NCT Number: NCT04089098
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Leipzig, Saxony, D-04103, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: immediately at the end of the MVC
changes in mean arterial pressure with PLR vs. MVC
Time frame: immediately at the end of the MVC
Changes in cardiac Output under PLR vs. MVC
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
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
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
University of Leipzig
Other
Characterizing VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility (VOLTA)
Acronym: VOLTA
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.
Published trials that share one or more normalized conditions with this study.
NCT07312071
Hemodynamic Instability, Infections
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT05953129
Cesarean Section Complications, Hemodynamic Instability
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06942091
Blunt Abdominal Trauma, Brain Diseases
View Trial DetailsNCT05676723
Acute Respiratory Distress Syndrome, Fluid Overload Pulmonary Edema
Le Kremlin-Bicêtre, Île-de-France Region, France
View Trial Details