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Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock

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The Washington University

Status

Completed

Conditions

Hypotension
Fluid Therapy
Septic Shock

Treatments

Other: Fluid minimization protocol
Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02473718
201310111

Details and patient eligibility

About

The purpose of the study is to determine if a protocol that assesses patients' daily fluid intake and output can decrease the overall amount of fluid patients receive during the first five days in the ICU. The study will also determine if decreasing overall fluids can decrease adverse events associated with mechanical ventilation, such as ventilator-associated pneumonias.

The protocol will include daily ultrasounds and blood draws to evaluate fluid balance. Ultrasound will be used to measure changes in the diameter of the inferior vena cava with respiration.

Enrollment

82 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adult patient with septic shock as the primary cause of hypotension
  2. Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment

Exclusion criteria

  1. Patients with a history of end-stage renal disease requiring outpatient dialysis
  2. Patients whose goals of care are consistent with comfort measures only
  3. Pregnant patients

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Fluid minimization group
Experimental group
Description:
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
Treatment:
Device: Ultrasound
Other: Fluid minimization protocol
Usual care group
No Intervention group
Description:
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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