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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Conservative Fluid Management Strategy

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.

Group Type EXPERIMENTAL

Conservative Fluid Management Strategy

Intervention Type 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.

Interventions

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Conservative Fluid Management Strategy

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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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