N/A N=30 Randomized Treatment

A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)

Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT02159079 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: ICU-free Days to 14 Days After Enrollment — 9; 11 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Conservative Fluid Management Strategy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY ICU-free Days to 14 Days After Enrollment	9; 11	—
SECONDARY Ventilator-free Days to Day 14	13; 12	—
SECONDARY In-hospital Mortality to Day 14	4; 3	—
SECONDARY Renal Replacement Therapy-free Days to Day 14	14; 14	—
SECONDARY Highest Stage of Acute Kidney Injury	5; 6; 0; 2; 4; 3	—
SECONDARY Highest Plasma Creatinine Between Enrollment and 28 Days After Enrollment	2.3; 1.3	—
SECONDARY Receipt of Renal Replacement Therapy	1; 1	—

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.

Eligibility Criteria

Inclusion Criteria

ICU patients
Adults
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
cervical spinal cord injury at level C5 or higher
amyotrophic lateral sclerosis
Guillain-Barré Syndrome
myasthenia gravis
Renal failure requiring renal replacement therapy
Burns >20% of body surface area
Pregnant
Preexisting pulmonary hypertension with PAPmean>40 on RHC
Severe chronic liver disease with Childs-Pugh Score >11
Moribund and not expected to survive an additional 24 hours
Actively withdrawing life support or transitioning to comfort measures only
Unwillingness of treating physician to employ conservative fluid strategy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02159079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.