Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-03 @ 7:26 AM
Study NCT ID:
NCT03395951
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2018-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Study Overview
Official Title:
Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
Detailed Description:
Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
Adverse events: No risks involved.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
Adverse events: No risks involved.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: