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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute respiratory failure | Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Discharged from hospital alive or expired | 28 Days |
| Ventilator-free days | Number of days of being alive and unassisted breathing by 28 days after time=0 | 28 Days |
| ICU-free days | Number of days alive and out of ICU-level care by 28 days after time=0 | 28 Days |
| Dialysis use | Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadexâ„¢) | 28 Days |
| Sequential Organ Failure Assessment (SOFA) | Mean and highest scores after T=0 | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration
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| Name | Affiliation | Role |
|---|---|---|
| Carl Shanholtz, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794169 | Background | 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. doi: 10.1056/NEJMoa010307. | |
| 10858412 | Background |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D004487 | Edema |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. doi: 10.1378/chest.117.6.1749. |
| 21615299 | Background | 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. |
| 16714767 | Background | 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. |
| 14578723 | Background | Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording 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. doi: 10.1097/01.sla.0000094387.50865.23. |
| 20693377 | Background | 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. |
| 25548524 | Background | 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. |
| 11594901 | Background | Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754. |
| D008171 | Lung Diseases |