drugset / Trial / NCT00624650
Hemodynamics and Extravascular Lung Water in Acute Lung Injury
Phase 2
Completed
33 enrolled
Oregon Health and Science University
Oregon Clinical and Translational Research Institute · collabPulsion Medical Systems · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to test a treatment that tries to reduce the amount of fluid in the lungs of subjects with acute lung injury to see if this is helpful.
Timeline
- Start
- 2008-02
- Primary completion
- 2011-01
- Completion
- 2011-01
Publications
- Background Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. doi: 10.1056/NEJM200005043421806. No abstract available.
- Background Matthay MA. Alveolar fluid clearance in patients with ARDS: does it make a difference? Chest. 2002 Dec;122(6 Suppl):340S-343S. doi: 10.1378/chest.122.6_suppl.340s.
- Background Mitchell JP, Schuller D, Calandrino FS, Schuster DP. Improved outcome based on fluid management in critically ill patients requiring pulmonary artery catheterization. Am Rev Respir Dis. 1992 May;145(5):990-8. doi: 10.1164/ajrccm/145.5.990.
- Background Eisenberg PR, Hansbrough JR, Anderson D, Schuster DP. A prospective study of lung water measurements during patient management in an intensive care unit. Am Rev Respir Dis. 1987 Sep;136(3):662-8. doi: 10.1164/ajrccm/136.3.662.
- 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.
- Background Bendjelid K, Romand JA. Fluid responsiveness in mechanically ventilated patients: a review of indices used in intensive care. Intensive Care Med. 2003 Mar;29(3):352-60. doi: 10.1007/s00134-002-1615-9. Epub 2003 Jan 21.
- Background Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
- Background Goedje O, Seebauer T, Peyerl M, Pfeiffer UJ, Reichart B. Hemodynamic monitoring by double-indicator dilution technique in patients after orthotopic heart transplantation. Chest. 2000 Sep;118(3):775-81. doi: 10.1378/chest.118.3.775.
- Background Bernard GR. Acute respiratory distress syndrome: a historical perspective. Am J Respir Crit Care Med. 2005 Oct 1;172(7):798-806. doi: 10.1164/rccm.200504-663OE. Epub 2005 Jul 14.
- Background Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.
- Background Matthay MA, Zimmerman GA. Acute lung injury and the acute respiratory distress syndrome: four decades of inquiry into pathogenesis and rational management. Am J Respir Cell Mol Biol. 2005 Oct;33(4):319-27. doi: 10.1165/rcmb.F305. No abstract available.
- Background Groeneveld AB, Polderman KH. Acute lung injury, overhydration or both? Crit Care. 2005 Apr;9(2):136-7. doi: 10.1186/cc3039. Epub 2005 Jan 17.
- Background Ware LB, Matthay MA. Alveolar fluid clearance is impaired in the majority of patients with acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1376-83. doi: 10.1164/ajrccm.163.6.2004035.
- Background Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6. doi: 10.1378/chest.122.6.2080.
- Background Phillips, C.R., Smith S. Extravascular Lung Water In Early ARDS ATS Poster Exhibit, 2006
- Background Sartori C, Matthay MA. Alveolar epithelial fluid transport in acute lung injury: new insights. Eur Respir J. 2002 Nov;20(5):1299-313. doi: 10.1183/09031936.02.00401602.
- Background Sporn P. Keep the lung dry--sense or nonsense? Acta Anaesthesiol Scand Suppl. 1996;109:63-5. No abstract available.
- Background Martin GS, Eaton S, Mealer M, Moss M. Extravascular lung water in patients with severe sepsis: a prospective cohort study. Crit Care. 2005 Apr;9(2):R74-82. doi: 10.1186/cc3025. Epub 2005 Jan 11.
- Background Martin GS, Moss M, Wheeler AP, Mealer M, Morris JA, Bernard GR. A randomized, controlled trial of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit Care Med. 2005 Aug;33(8):1681-7. doi: 10.1097/01.ccm.0000171539.47006.02.
- Background Perkins GD, McAuley DF, Thickett DR, Gao F. The beta-agonist lung injury trial (BALTI): a randomized placebo-controlled clinical trial. Am J Respir Crit Care Med. 2006 Feb 1;173(3):281-7. doi: 10.1164/rccm.200508-1302OC. Epub 2005 Oct 27.
- Background Elings VB, Lewis FR. A single indicator technique to estimate extravascular lung water. J Surg Res. 1982 Nov;33(5):375-85. doi: 10.1016/0022-4804(82)90052-x.
- Background Mihm FG, Feeley TW, Rosenthal MH, Lewis F. Measurement of extravascular lung water in dogs using the thermal-green dye indicator dilution method. Anesthesiology. 1982 Aug;57(2):116-22. doi: 10.1097/00000542-198208000-00009.
- Background Mihm FG, Feeley TW, Jamieson SW. Thermal dye double indicator dilution measurement of lung water in man: comparison with gravimetric measurements. Thorax. 1987 Jan;42(1):72-6. doi: 10.1136/thx.42.1.72.
- Background Sivak ED, Tita J, Meden G, Ishigami M, Graves J, Kavlich J, Stowe NT, Magnusson MO. Effects of furosemide versus isolated ultrafiltration on extravascular lung water in oleic acid-induced pulmonary edema. Crit Care Med. 1986 Jan;14(1):48-51. doi: 10.1097/00003246-198601000-00011.
- Background Wickerts CJ, Blomqvist H, Berg B, Rosblad PG, Hedenstierna G. Furosemide, when used in combination with positive end-expiratory pressure, facilitates the resorption of extravascular lung water in experimental hydrostatic pulmonary oedema. Acta Anaesthesiol Scand. 1991 Nov;35(8):776-83. doi: 10.1111/j.1399-6576.1991.tb03390.x.
- Background Waugh JB, Op't Holt TB, Gadek JE, Clanton TL. High-dose furosemide alters gas exchange in a model of acute lung injury. J Crit Care. 1996 Sep;11(3):129-37. doi: 10.1016/s0883-9441(96)90009-x.
- Background Reising CA, Chendrasekhar A, Wall PL, Paradise NF, Timberlake GA, Moorman DW. Continuous dose furosemide as a therapeutic approach to acute respiratory distress syndrome (ARDS). J Surg Res. 1999 Mar;82(1):56-60. doi: 10.1006/jsre.1998.5513.
- Background Martin GS. Fluid balance and colloid osmotic pressure in acute respiratory failure: emerging clinical evidence. Crit Care. 2000;4 Suppl 2(Suppl 2):S21-5. doi: 10.1186/cc966. Epub 2000 Oct 13.
- Background Martin GS, Mangialardi RJ, Wheeler AP, Dupont WD, Morris JA, Bernard GR. Albumin and furosemide therapy in hypoproteinemic patients with acute lung injury. Crit Care Med. 2002 Oct;30(10):2175-82. doi: 10.1097/00003246-200210000-00001.
- Background Mojtahedzadeh M, Vazin A, Najafi A, Khalilzadeh A, Abdollahi M. The effect of furosemide infusion on serum epidermal growth factor concentration after acute lung injury. J Infus Nurs. 2005 May-Jun;28(3):188-93. doi: 10.1097/00129804-200505000-00007.
- Background Molloy WD, Lee KY, Girling L, Prewitt RM. Treatment of canine permeability pulmonary edema: short-term effects of dobutamine, furosemide, and hydralazine. Circulation. 1985 Dec;72(6):1365-71. doi: 10.1161/01.cir.72.6.1365.
- Background Ali J, Wood LD. Pulmonary vascular effects of furosemide on gas exchange in pulmonary edema. J Appl Physiol Respir Environ Exerc Physiol. 1984 Jul;57(1):160-7. doi: 10.1152/jappl.1984.57.1.160.
- Background Ali J, Unruh H, Skoog C, Goldberg HS. The effect of lung edema on pulmonary vasoactivity of furosemide. J Surg Res. 1983 Nov;35(5):383-90. doi: 10.1016/0022-4804(83)90027-6.
- Background Ali J, Chernicki W, Wood LD. Effect of furosemide in canine low-pressure pulmonary edema. J Clin Invest. 1979 Nov;64(5):1494-504. doi: 10.1172/JCI109608.
- Background Hechtman HB, Weisel RD, Vito L, Ali J, Berger RL. The independence of pulmonary shunting and pulmonary edema. Surgery. 1973 Aug;74(2):300-6. No abstract available.
- Background Baltopoulos G, Zakynthinos S, Dimopoulos A, Roussos C. Effects of furosemide on pulmonary shunts. Chest. 1989 Sep;96(3):494-8. doi: 10.1378/chest.96.3.494.
- Background Boussat S, Jacques T, Levy B, Laurent E, Gache A, Capellier G, Neidhardt A. Intravascular volume monitoring and extravascular lung water in septic patients with pulmonary edema. Intensive Care Med. 2002 Jun;28(6):712-8. doi: 10.1007/s00134-002-1286-6. Epub 2002 May 18.
- Background Halperin BD, Feeley TW, Mihm FG, Chiles C, Guthaner DF, Blank NE. Evaluation of the portable chest roentgenogram for quantitating extravascular lung water in critically ill adults. Chest. 1985 Nov;88(5):649-52. doi: 10.1378/chest.88.5.649.
- Background Meade MO, Cook RJ, Guyatt GH, Groll R, Kachura JR, Bedard M, Cook DJ, Slutsky AS, Stewart TE. Interobserver variation in interpreting chest radiographs for the diagnosis of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2000 Jan;161(1):85-90. doi: 10.1164/ajrccm.161.1.9809003.
- Background Baudendistel L, Shields JB, Kaminski DL. Comparison of double indicator thermodilution measurements of extravascular lung water (EVLW) with radiographic estimation of lung water in trauma patients. J Trauma. 1982 Dec;22(12):983-8. doi: 10.1097/00005373-198212000-00002.
- Background Roch A, Michelet P, Lambert D, Delliaux S, Saby C, Perrin G, Ghez O, Bregeon F, Thomas P, Carpentier JP, Papazian L, Auffray JP. Accuracy of the double indicator method for measurement of extravascular lung water depends on the type of acute lung injury. Crit Care Med. 2004 Mar;32(3):811-7. doi: 10.1097/01.ccm.0000114831.59185.02.
- Background Kirov MY, Kuzkov VV, Kuklin VN, Waerhaug K, Bjertnaes LJ. Extravascular lung water assessed by transpulmonary single thermodilution and postmortem gravimetry in sheep. Crit Care. 2004 Dec;8(6):R451-8. doi: 10.1186/cc2974. Epub 2004 Oct 19.
- Background Rossi P, Oldner A, Wanecek M, Leksell LG, Rudehill A, Konrad D, Weitzberg E. Comparison of gravimetric and a double-indicator dilution technique for assessment of extra-vascular lung water in endotoxaemia. Intensive Care Med. 2003 Mar;29(3):460-6. doi: 10.1007/s00134-002-1604-z. Epub 2003 Feb 8.
- Background Katzenelson R, Perel A, Berkenstadt H, Preisman S, Kogan S, Sternik L, Segal E. Accuracy of transpulmonary thermodilution versus gravimetric measurement of extravascular lung water. Crit Care Med. 2004 Jul;32(7):1550-4. doi: 10.1097/01.ccm.0000130995.18334.8b.
- Background Fernandez-Mondejar E, Rivera-Fernandez R, Garcia-Delgado M, Touma A, Machado J, Chavero J. Small increases in extravascular lung water are accurately detected by transpulmonary thermodilution. J Trauma. 2005 Dec;59(6):1420-3; discussion 1424. doi: 10.1097/01.ta.0000198360.01080.42.
- Background Nuckton TJ, Alonso JA, Kallet RH, Daniel BM, Pittet JF, Eisner MD, Matthay MA. Pulmonary dead-space fraction as a risk factor for death in the acute respiratory distress syndrome. N Engl J Med. 2002 Apr 25;346(17):1281-6. doi: 10.1056/NEJMoa012835.
- Background Tavernier B, Makhotine O, Lebuffe G, Dupont J, Scherpereel P. Systolic pressure variation as a guide to fluid therapy in patients with sepsis-induced hypotension. Anesthesiology. 1998 Dec;89(6):1313-21. doi: 10.1097/00000542-199812000-00007.
- Background Calvin JE, Driedger AA, Sibbald WJ. The hemodynamic effect of rapid fluid infusion in critically ill patients. Surgery. 1981 Jul;90(1):61-76.
- Background Schneider AJ, Teule GJ, Groeneveld AB, Nauta J, Heidendal GA, Thijs LG. Biventricular performance during volume loading in patients with early septic shock, with emphasis on the right ventricle: a combined hemodynamic and radionuclide study. Am Heart J. 1988 Jul;116(1 Pt 1):103-12. doi: 10.1016/0002-8703(88)90256-6.
- Background Reuse C, Vincent JL, Pinsky MR. Measurements of right ventricular volumes during fluid challenge. Chest. 1990 Dec;98(6):1450-4. doi: 10.1378/chest.98.6.1450.
- Background Wagner JG, Leatherman JW. Right ventricular end-diastolic volume as a predictor of the hemodynamic response to a fluid challenge. Chest. 1998 Apr;113(4):1048-54. doi: 10.1378/chest.113.4.1048.
- Background Magder S, Lagonidis D. Effectiveness of albumin versus normal saline as a test of volume responsiveness in post-cardiac surgery patients. J Crit Care. 1999 Dec;14(4):164-71. doi: 10.1016/s0883-9441(99)90030-8.
- Background Tousignant CP, Walsh F, Mazer CD. The use of transesophageal echocardiography for preload assessment in critically ill patients. Anesth Analg. 2000 Feb;90(2):351-5. doi: 10.1097/00000539-200002000-00021.
- Background 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. doi: 10.1164/ajrccm.162.1.9903035.
- Background Feissel M, Michard F, Mangin I, Ruyer O, Faller JP, Teboul JL. Respiratory changes in aortic blood velocity as an indicator of fluid responsiveness in ventilated patients with septic shock. Chest. 2001 Mar;119(3):867-73. doi: 10.1378/chest.119.3.867.
- Background Martin GS, Ely EW, Carroll FE, Bernard GR. Findings on the portable chest radiograph correlate with fluid balance in critically ill patients. Chest. 2002 Dec;122(6):2087-95. doi: 10.1378/chest.122.6.2087.
- Background Ely EW, Smith AC, Chiles C, Aquino SL, Harle TS, Evans GW, Haponik EF. Radiologic determination of intravascular volume status using portable, digital chest radiography: a prospective investigation in 100 patients. Crit Care Med. 2001 Aug;29(8):1502-12. doi: 10.1097/00003246-200108000-00002.
- Background Michard F. Underutilized tools for the assessment of intravascular volume status. Chest. 2003 Jul;124(1):414-5; author reply 415-6. No abstract available.
- Background Connors AF Jr. The role of right heart catheterization in the care of the critically ill: benefits, limitations, and risks. Int J Cardiol. 1983 Nov-Dec;4(4):474-7. doi: 10.1016/0167-5273(83)90200-0. No abstract available.
- Background Diebel LN, Wilson RF, Tagett MG, Kline RA. End-diastolic volume. A better indicator of preload in the critically ill. Arch Surg. 1992 Jul;127(7):817-21; discussion 821-2. doi: 10.1001/archsurg.1992.01420070081015.
- Background Tomicic V, Graf J, Echevarria G, Espinoza M, Abarca J, Montes JM, Torres J, Nunez G, Guerrero J, Luppi M, Canals C. [Intrathoracic blood volume versus pulmonary artery occlusion pressure as estimators of cardiac preload in critically ill patients]. Rev Med Chil. 2005 Jun;133(6):625-31. doi: 10.4067/s0034-98872005000600001. Epub 2005 Jul 22. Spanish.
- Background Szakmany T, Toth I, Kovacs Z, Leiner T, Mikor A, Koszegi T, Molnar Z. Effects of volumetric vs. pressure-guided fluid therapy on postoperative inflammatory response: a prospective, randomized clinical trial. Intensive Care Med. 2005 May;31(5):656-63. doi: 10.1007/s00134-005-2606-4. Epub 2005 Apr 6.
- Background Nirmalan M, Willard TM, Edwards DJ, Little RA, Dark PM. Estimation of errors in determining intrathoracic blood volume using the single transpulmonary thermal dilution technique in hypovolemic shock. Anesthesiology. 2005 Oct;103(4):805-12. doi: 10.1097/00000542-200510000-00019.
- Background Hofmann D, Klein M, Wegscheider K, Sakka SG. [Extended hemodynamic monitoring using transpulmonary thermodilution Influence of various factors on the accuracy of the estimation of intrathoracic blood volume and extravascular lung water in critically ill patients]. Anaesthesist. 2005 Apr;54(4):319-26. doi: 10.1007/s00101-005-0809-2. German.
- Background Donati A, Loggi S, Coltrinari R, Pelaia P. Intrathoracic blood volume as index of cardiac output variations. Acta Anaesthesiol Scand. 2004 Mar;48(3):386-7. doi: 10.1111/j.0001-5172.2004.0320c.x. No abstract available.
- Background Sakka SG, Meier-Hellmann A. Intrathoracic blood volume in a patient with pulmonary embolism. Eur J Anaesthesiol. 2003 Mar;20(3):256-7. doi: 10.1017/s0265021503230428. No abstract available.
- Background Kuz'kov VV, Kirov MIu, Nedashkovskii EV. [Volumetric monitoring based on transpulmonary thermodilution in anesthesiology and intensive care]. Anesteziol Reanimatol. 2003 Jul-Aug;(4):67-73. Russian.
- Background Reuter DA, Felbinger TW, Moerstedt K, Weis F, Schmidt C, Kilger E, Goetz AE. Intrathoracic blood volume index measured by thermodilution for preload monitoring after cardiac surgery. J Cardiothorac Vasc Anesth. 2002 Apr;16(2):191-5. doi: 10.1053/jcan.2002.31064.
- 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.
- Background Eisner MD, Thompson T, Hudson LD, Luce JM, Hayden D, Schoenfeld D, Matthay MA; Acute Respiratory Distress Syndrome Network. Efficacy of low tidal volume ventilation in patients with different clinical risk factors for acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 Jul 15;164(2):231-6. doi: 10.1164/ajrccm.164.2.2011093.
- Background Doyle RL, Szaflarski N, Modin GW, Wiener-Kronish JP, Matthay MA. Identification of patients with acute lung injury. Predictors of mortality. Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):1818-24. doi: 10.1164/ajrccm.152.6.8520742.
- Background Frezza EE, Mezghebe H. Indications and complications of arterial catheter use in surgical or medical intensive care units: analysis of 4932 patients. Am Surg. 1998 Feb;64(2):127-31.
- Background Dorman T, Breslow MJ, Lipsett PA, Rosenberg JM, Balser JR, Almog Y, Rosenfeld BA. Radial artery pressure monitoring underestimates central arterial pressure during vasopressor therapy in critically ill surgical patients. Crit Care Med. 1998 Oct;26(10):1646-9. doi: 10.1097/00003246-199810000-00014.
- Background MacIntyre NR. Current issues in mechanical ventilation for respiratory failure. Chest. 2005 Nov;128(5 Suppl 2):561S-567S. doi: 10.1378/chest.128.5_suppl_2.561S.
- Background Steinberg KP, Mitchell DR, Maunder RJ, Milberg JA, Whitcomb ME, Hudson LD. Safety of bronchoalveolar lavage in patients with adult respiratory distress syndrome. Am Rev Respir Dis. 1993 Sep;148(3):556-61. doi: 10.1164/ajrccm/148.3.556.
- Background Brown DL, Hungness ES, Campbell RS, Luchette FA. Ventilator-associated pneumonia in the surgical intensive care unit. J Trauma. 2001 Dec;51(6):1207-16. doi: 10.1097/00005373-200112000-00034. No abstract available.
- Background Rouby JJ, Martin De Lassale E, Poete P, Nicolas MH, Bodin L, Jarlier V, Le Charpentier Y, Grosset J, Viars P. Nosocomial bronchopneumonia in the critically ill. Histologic and bacteriologic aspects. Am Rev Respir Dis. 1992 Oct;146(4):1059-66. doi: 10.1164/ajrccm/146.4.1059.
- Background Chesnutt AN, Matthay MA, Tibayan FA, Clark JG. Early detection of type III procollagen peptide in acute lung injury. Pathogenetic and prognostic significance. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):840-5. doi: 10.1164/ajrccm.156.3.9701124.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Furosemide | Other / unclassified | 3 mg | Intravenous |
| Subject | Furosemide | Other / unclassified | — | — |
| Comparator | Dobutamine | Small molecule | — | — |
| Background | Epinephrine | Other / unclassified | — | — |
| Background | Norepinephrine | Other / unclassified | — | — |
| Background | Phenylephrine | Small molecule | — | — |
| Background | Vasopressin | Peptide | 0.04 iu | — |