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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473718
• Other study ID #: 201310111
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: February 27, 2018
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Therapy
• Hypotension
• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• 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.

Device:
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

References & Publications (10)

Alsous F, Khamiees M, DeGirolamo A, Amoateng-Adjepong Y, Manthous CA. Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest. 2000 Jun;117(6):1749-54. — View Citation

Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. — View Citation

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af. — View Citation

Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331. Review. — View Citation

Marik PE, Baram M. Noninvasive hemodynamic monitoring in the intensive care unit. Crit Care Clin. 2007 Jul;23(3):383-400. Review. — View Citation

Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. — View Citation

Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review. — View Citation

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. Epub 2006 May 21. — View Citation

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. — View Citation

Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Fluid Administered	Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3	Day 3
Primary	Cumulative Fluid Administered	Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5	Day 5
Primary	Net Fluid Balance	Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3	Day 3
Primary	Net Fluid Balance	Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5	Day 5
Secondary	Ventilator Days	Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation	Hospital stay, median of 16 days
Secondary	Rate of Renal Replacement Therapy	Percentage of patients requiring renal replacement therapy	ICU stay, median of 10 days
Secondary	Mortality	Percentage of patients who died during their hospitalization	Hospital stay, median of 16 days
Secondary	Mortality	Percentage of patients who died during their ICU stay	ICU stay, median of 10 days