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

NCT02159079 | Completed Results

• 1 other identifier: 140582
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Sepsis; Severe Sepsis; Septic Shock; Conservative Fluid Management; Fluid Balance; Fluid Restriction

Outcome Measures

Primary Outcomes (1)

• ICU-free Days to 14 Days After Enrollment

  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).

  14 days

Secondary Outcomes (6)

• Ventilator-free Days to Day 14

  14 days

• In-hospital Mortality to Day 14

  14 days

• Renal Replacement Therapy-free Days to Day 14

  14 days

• Highest Stage of Acute Kidney Injury

  28 days

• Highest Plasma Creatinine Between Enrollment and 28 Days After Enrollment

  28 days

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in the usual care arm will be managed exclusively by their treating clinician without input from study personnel.

Conservative Fluid Management Strategy

EXPERIMENTAL

For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.

Other: Conservative Fluid Management Strategy

Interventions

Conservative Fluid Management Strategy OTHER

For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.

Conservative Fluid Management Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to obtain consent
• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Semler MW, Janz DR, Casey JD, Self WH, Rice TW. Conservative Fluid Management After Sepsis Resuscitation: A Pilot Randomized Trial. J Intensive Care Med. 2020 Dec;35(12):1374-1382. doi: 10.1177/0885066618823183. Epub 2019 Jan 10.

  PMID: 30630380 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Matthew W. Semler, MD, MSc
• Organization: VANDERBILT UNIVERSITY MEDICAL CENTER

matthew.w.semler@vumc.org

(615) 322-3412

Study Officials

• Matthew W. Semler, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 9, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

US (1)