A Phase II/III Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Vanderbilt University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- ICU-free Days to 14 Days After Enrollment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic patients treated in the intensive care unit commonly receive significant volumes of intravenous fluids with resultant positive fluid balance for up to a week after their initial resuscitation. Observational studies have associated fluid receipt and positive fluid balance in patients with severe sepsis and septic shock with increased mortality but are inherently limited by indication bias. In order to determine the optimal approach to fluid management following resuscitation in patients with severe sepsis and septic shock, a randomized controlled trial is needed. The primary hypothesis of this study is that, compared to usual care, a conservative approach to fluid management after resuscitation in patients with sepsis and cardiopulmonary dysfunction will increase intensive care unit free days.
Investigators
Matthew Semler
Fellow in Pulmonary and Critical Care Medicine
Vanderbilt University
Eligibility Criteria
Inclusion Criteria
- •ICU patients
- •Sepsis as defined by at least two systemic inflammatory response syndrome criteria and receipt of antimicrobial therapy
- •Cardiopulmonary dysfunction as defined shock or respiratory failure
Exclusion Criteria
- •Inability to obtain consent
- •Greater than 48 hours since inclusion criteria initially met
- •Allergy to furosemide AND bumetanide
- •Rhabdomyolysis with creatinine kinase \> 5000 U/L
- •Hypercalcemia with calcium \>11 mg/dL
- •Diabetic Ketoacidosis requiring continuous insulin infusion
- •Tumor Lysis Syndrome diagnosed clinically
- •Pancreatitis diagnosed clinically
- •Chronic Hypoxic Respiratory Failure with Home Oxygen Use of FiO2≥0.3
- •Chronic ventilator dependence
Outcomes
Primary Outcomes
ICU-free Days to 14 Days After Enrollment
Time Frame: 14 days
The primary outcome will be the number of ICU-free days to day 14 (defined as the number days alive and outside of the intensive care unit in the first 14 days after enrollment).
Secondary Outcomes
- Renal Replacement Therapy-free Days to Day 14(14 days)
- Highest Plasma Creatinine Between Enrollment and 28 Days After Enrollment(28 days)
- In-hospital Mortality to Day 14(14 days)
- Highest Stage of Acute Kidney Injury(28 days)
- Ventilator-free Days to Day 14(14 days)
- Receipt of Renal Replacement Therapy(28 days)