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

NCT ID: NCT02473718

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

Septic Shock; Fluid Therapy; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluid minimization group

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.

Group Type: EXPERIMENTAL

Fluid minimization protocol

Intervention Type: OTHER

Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance in patients demonstrating fluid non-responsiveness.

Ultrasound

Intervention Type: DEVICE

Usual care group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluid minimization protocol

Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance in patients demonstrating fluid non-responsiveness.

Intervention Type: OTHER

Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 26291900 (View on PubMed)

Other Identifiers

201310111

Identifier Type: -

Identifier Source: org_study_id