Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

NCT03395951 | Completed DMC

• 1 other identifier: n-WMO 2014-43
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Heart Failure; Heart Diseases; Septic Shock; Surgery; Critically Ill

Keywords

Mean Systemic Filling Pressure; Diuretics; Pressure for venous return; Fluid Balance; De-escalation fluid therapy; De-resuscitation; Guyton; Guytonian Approach; Furosemide; Cardiac Output; Cardiac Index

Outcome Measures

Primary Outcomes (1)

• Change in mean systemic filling pressure (mmHg)

  Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

Secondary Outcomes (17)

• Change in cardiac index (L/min/m2)

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

• Change in mean arterial pressure (mmHg)

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

• Change in central venous pressure (mmHg)

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

• Change in pressure for venous return (mmHg)

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

• Change in resistance to venous return (dynes⋅sec⋅cm-5)

  Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

Interventions

Diuretics DRUG

Observation of hemodynamics during diuretics treatment within clinical indication.

Also known as: Diuretic therapy

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 patients with a clinical indication for treatment with intravenous diuretics

You may qualify if:

• Patients must be at least 18 years
• PiCCO in situ (cardiac output device applied in light of clinical treatment)
• CVL in situ
• Clinical indication for continuous furosemide administration

You may not qualify if:

• Patients younger then 18 years
• Patients without PiCCO
• Pregnant women

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Sepsis; Heart Failure; Heart Diseases; Shock, Septic; Critical Illness

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jan Bakker, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 10, 2018
• Study Start: October 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 31, 2015
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Years
• Access Criteria: Negotiable

Locations

NL (1)