Description of Fluid Balance in Patients With Acute Respiratory Failure

Respiratory Insufficiency Clinical Trial

Official title:

Description of Fluid Balance in Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02523872
• Other study ID #: HP-00064591
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 13, 2015
• Last updated: August 13, 2015
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Smiths Medical, ASD, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The specific aim of this study is to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration.

Description:

Disruption of fluid balance is common in critical illness. Many critical illnesses are inflammatory in nature and associated with capillary leak and swelling of tissues. While fluid administration may be necessary for the immediate resuscitation of a patient in shock, in the long term it may worsen survival and lead to complications. This is especially true in acute respiratory failure, where excess fluid can lead to a longer duration of mechanical ventilation, longer time in the ICU, and a greater need for dialysis. There is also evidence that conservative fluid administration can prevent complications. Fluid overload is associated with increased healthcare resource utilization and cost.

Much of the fluid administered to patients while in the adult ICU in the United States is administered as medications via large volume infusion pumps. This is a descriptive study to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration. The information will be used to design an interventional trial of small volume medication infusion.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intubation and mechanical ventilation for = 7 days

• An underlying condition associated with acute respiratory failure (e.g. pneumonia, ARDS, sepsis, asthma, COPD exacerbation)

• If in shock (MAP < 60, fluid bolus =30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine = 5 mcg/kg/min or low-dose (= 0.04 IU/min) vasopressin) there should be no fluid bolus (1000 mL crystalloid or equivalent) for at least 12 hours

Exclusion Criteria:

• Intubation or mechanical ventilation for > 7 days

• Respiratory failure (requirement for positive pressure ventilation) in past 30 days

• Shock (MAP < 60, fluid bolus =30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine = 5 mcg/kg/min or low-dose vasopressin) requiring fluid bolus (1000 mL crystalloid or equivalent) within past 12 hours

• Presence of a condition making it unlikely that the patient will be liberated from mechanical ventilation within the next 28 days (e.g. quadriplegia, end-stage lung disease, massive stroke, etc.)

• Prognosis from underlying condition = 28 days (estimated 28 day mortality from underlying condition >50%)

• Likely intention (>50% probability) to withhold or withdraw life-supportive care within next 28 days

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Smiths Medical, ASD, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

Brandstrup B, Tønnesen H, Beier-Holgersen R, Hjortsø E, Ørding H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. — View Citation

Child DL, Cao Z, Seiberlich LE, Brown H, Greenberg J, Swanson A, Sewall MR, Robinson SB. The costs of fluid overload in the adult intensive care unit: is a small-volume infusion model a proactive solution? Clinicoecon Outcomes Res. 2014 Dec 15;7:1-8. doi: 10.2147/CEOR.S72776. eCollection 2015. — View Citation

Ferreira FL, Bota DP, Bross A, Mélot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. — View Citation

Li G, Malinchoc M, Cartin-Ceba R, Venkata CV, Kor DJ, Peters SG, Hubmayr RD, Gajic O. Eight-year trend of acute respiratory distress syndrome: a population-based study in Olmsted County, Minnesota. Am J Respir Crit Care Med. 2011 Jan 1;183(1):59-66. doi: 10.1164/rccm.201003-0436OC. Epub 2010 Aug 6. — View Citation

Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Discharged from hospital alive or expired	28 Days	No
Primary	Ventilator-free days	Number of days of being alive and unassisted breathing by 28 days after time=0	28 Days	No
Primary	ICU-free days	Number of days alive and out of ICU-level care by 28 days after time=0	28 Days	No
Primary	Dialysis use	Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™)	28 Days	No
Primary	Sequential Organ Failure Assessment (SOFA)	Mean and highest scores after T=0	28 Days	No