Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. There is little Canadian data regarding ICU survival and regarding 1-year survival and functional outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of up to date long-term outcome data. This information will facilitate a better understanding who would best benefit from critical care interventions and the impact of critical illness on their level of function at 1 year as well as survival.
At the time of ICU admission, the investigators will collect clinical data from the medical chart on a daily basis including demographics, pre-existing disease(s), treatment and reason for ICU admission.
At the time of ICU discharge, the investigators will measure exercise tolerance and quality of life at 3 time intervals (Phase 2).
For Phase 2, patients will be seen at day 7 following ICU discharge, 6 months following ICU discharge and 12 months after ICU discharge during their routine oncology follow up visits. During these visits, they will undergo a functional assessment (6 minute walk test) and questionnaires to determine their quality of life following ICU (validated outcome measures).
All patients will complete outcome measures 1 to 5 below; Outcome measures 1 to 3 will be administered at 7 days and 1 to 5 at 6 months and 12 months after ICU discharge.
Validated Outcomes Measures:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 1 year survival | 1 year survival in enrolled patients | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit survival | ICU survival in enrolled patients | 1 year |
| 6 month functional outcome measured by the 6 minute walk test (6MWT) | 6MWT will be performed to assess exercise capacity at 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with hematologic malignancy (HM) and hematopoietic cell transplantation (HCT) frequently develop life-threatening illness and require admission to an intensive care unit (ICU). In light of advancements in care and extension of treatments to much higher risk candidates, survival and functional outcome evaluation become crucial for informed development of practice guidelines to guide pre-ICU risk stratification, as well as ICU and post-ICU care. Robust and up to date long-term data on ICU morbidity and mortality outcomes are lacking.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Laveena Munshi, MD, FRCPC | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital | Calgary | Alberta | T2N 2T9 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10199547 | Background | Guidelines for intensive care unit admission, discharge, and triage. Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med. 1999 Mar;27(3):633-8. | |
| 20920175 | Background | Roze des Ordons AL, Chan K, Mirza I, Townsend DR, Bagshaw SM. Clinical characteristics and outcomes of patients with acute myelogenous leukemia admitted to intensive care: a case-control study. BMC Cancer. 2010 Sep 28;10:516. doi: 10.1186/1471-2407-10-516. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| 6 month Functional Independent Measure questionnaire (FIM) | FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs. | 6 months |
| 6 month Clinical Frailty Scale (CFS) | CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution | 6 months |
| 6 month Short Form 36 Health Questionnaire (SF 36) | SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition. | 6 months |
| 6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) | FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life. | 6 months |
| 1 year functional outcome measured by the 6 minute walk test (6MWT) | 6MWT will be performed to assess exercise capacity at 6 months | 1 year |
| 1 year Functional Independent Measure questionnaire (FIM) | FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs. | 1 year |
| 1 year Clinical Frailty Scale (CFS) | CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution | 1 year |
| 1 year Short Form 36 Health Questionnaire (SF 36) | SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition. | 1 year |
| 1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) | FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life. | 1 year |
| Edmonton |
| Alberta |
| T6G 2R3 |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3T 2N2 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Juravinski Hospital | Hamilton | Ontario | L8V 1C3 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| 27445571 | Background | Cornish M, Butler MB, Green RS. Predictors of Poor Outcomes in Critically Ill Adults with Hematologic Malignancy. Can Respir J. 2016;2016:9431385. doi: 10.1155/2016/9431385. Epub 2016 Feb 24. |
| 27445524 | Background | Kraguljac AP, Croucher D, Christian M, Ibrahimova N, Kumar V, Jacob G, Kiss A, Minden MD, Mehta S. Outcomes and Predictors of Mortality for Patients with Acute Leukemia Admitted to the Intensive Care Unit. Can Respir J. 2016;2016:3027656. doi: 10.1155/2016/3027656. Epub 2016 Jun 30. |
| 18936734 | Background | Trinkaus MA, Lapinsky SE, Crump M, Keating A, Reece DE, Chen C, Hallett DC, Franke N, Winter A, Mikhael JR. Predictors of mortality in patients undergoing autologous hematopoietic cell transplantation admitted to the intensive care unit. Bone Marrow Transplant. 2009 Mar;43(5):411-5. doi: 10.1038/bmt.2008.336. Epub 2008 Oct 20. |
| 18547422 | Background | Scales DC, Thiruchelvam D, Kiss A, Sibbald WJ, Redelmeier DA. Intensive care outcomes in bone marrow transplant recipients: a population-based cohort analysis. Crit Care. 2008;12(3):R77. doi: 10.1186/cc6923. Epub 2008 Jun 11. |
| 26807683 | Background | Yadav H, Nolan ME, Bohman JK, Cartin-Ceba R, Peters SG, Hogan WJ, Gajic O, Kor DJ. Epidemiology of Acute Respiratory Distress Syndrome Following Hematopoietic Stem Cell Transplantation. Crit Care Med. 2016 Jun;44(6):1082-90. doi: 10.1097/CCM.0000000000001617. |
| 18348307 | Background | Thakkar SG, Fu AZ, Sweetenham JW, Mciver ZA, Mohan SR, Ramsingh G, Advani AS, Sobecks R, Rybicki L, Kalaycio M, Sekeres MA. Survival and predictors of outcome in patients with acute leukemia admitted to the intensive care unit. Cancer. 2008 May 15;112(10):2233-40. doi: 10.1002/cncr.23394. |
| Background | Cuthbertson BH, Rajalingam Y, Harrison S, McKirdy F, On behalf of the Scottish Intensive Care Society. The outcome of haematological malignancy in Scottish intensive care units. JICS 2008; 9 (2) |
| 22298243 | Background | Bird GT, Farquhar-Smith P, Wigmore T, Potter M, Gruber PC. Outcomes and prognostic factors in patients with haematological malignancy admitted to a specialist cancer intensive care unit: a 5 yr study. Br J Anaesth. 2012 Mar;108(3):452-9. doi: 10.1093/bja/aer449. Epub 2012 Jan 31. |
| Background | Hampshire PA, Pugh R, Hajimichael P. Outcomes for critically ill patients with haematological malignancies in specialist and non-specialist centres in the United Kingdom. Journal of Cancer Therapeutics & Research 2014, http://www.hoajonline.com/journals/pdf/2049-7962-3-5.pdf |
| 25310461 | Background | Grgic Medic M, Gornik I, Gasparovic V. Hematologic malignancies in the medical intensive care unit--Outcomes and prognostic factors. Hematology. 2015 Jun;20(5):247-53. doi: 10.1179/1607845414Y.0000000206. Epub 2014 Oct 13. |
| 23752112 | Background | Azoulay E, Mokart D, Pene F, Lambert J, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Laisne LM, Rabbat A, Lebert C, Perez P, Chaize M, Renault A, Meert AP, Benoit D, Hamidfar R, Jourdain M, Darmon M, Schlemmer B, Chevret S, Lemiale V. Outcomes of critically ill patients with hematologic malignancies: prospective multicenter data from France and Belgium--a groupe de recherche respiratoire en reanimation onco-hematologique study. J Clin Oncol. 2013 Aug 1;31(22):2810-8. doi: 10.1200/JCO.2012.47.2365. Epub 2013 Jun 10. |
| 25578678 | Background | Mokart D, Darmon M, Resche-Rigon M, Lemiale V, Pene F, Mayaux J, Rabbat A, Kouatchet A, Vincent F, Nyunga M, Bruneel F, Lebert C, Perez P, Renault A, Hamidfar R, Jourdain M, Meert AP, Benoit D, Chevret S, Azoulay E. Prognosis of neutropenic patients admitted to the intensive care unit. Intensive Care Med. 2015 Feb;41(2):296-303. doi: 10.1007/s00134-014-3615-y. Epub 2015 Jan 13. |
| 25798675 | Background | Lengline E, Chevret S, Moreau AS, Pene F, Blot F, Bourhis JH, Buzyn A, Schlemmer B, Socie G, Azoulay E. Changes in intensive care for allogeneic hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2015 Jun;50(6):840-5. doi: 10.1038/bmt.2015.55. Epub 2015 Mar 23. |
| 26429355 | Background | Lemiale V, Resche-Rigon M, Mokart D, Pene F, Rabbat A, Kouatchet A, Vincent F, Bruneel F, Nyunga M, Lebert C, Perez P, Meert AP, Benoit D, Chevret S, Azoulay E. Acute respiratory failure in patients with hematological malignancies: outcomes according to initial ventilation strategy. A groupe de recherche respiratoire en reanimation onco-hematologique (Grrr-OH) study. Ann Intensive Care. 2015 Dec;5(1):28. doi: 10.1186/s13613-015-0070-z. Epub 2015 Sep 30. |
| 25917260 | Background | Champigneulle B, Merceron S, Lemiale V, Geri G, Mokart D, Bruneel F, Vincent F, Perez P, Mayaux J, Cariou A, Azoulay E. What is the outcome of cancer patients admitted to the ICU after cardiac arrest? Results from a multicenter study. Resuscitation. 2015 Jul;92:38-44. doi: 10.1016/j.resuscitation.2015.04.011. Epub 2015 Apr 24. |
| 26974173 | Background | Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, Santos CD, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Cameron JI; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. The RECOVER Program: Disability Risk Groups and 1-Year Outcome after 7 or More Days of Mechanical Ventilation. Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. doi: 10.1164/rccm.201512-2343OC. |
| 26306719 | Background | Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26. |
| 26784775 | Background | Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603. |
| 23353941 | Background | 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. |
| 26287443 | Background | Wise MP, Barnes RA, Baudouin SV, Howell D, Lyttelton M, Marks DI, Morris EC, Parry-Jones N; British Committee for Standards in Haematology. Guidelines on the management and admission to intensive care of critically ill adult patients with haematological malignancy in the UK. Br J Haematol. 2015 Oct;171(2):179-188. doi: 10.1111/bjh.13594. Epub 2015 Aug 19. No abstract available. |
| 23180503 | Background | Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. |
| 28142306 | Background | Liu J, Bell C, Campbell V, DeBacker J, Tamberg E, Lee C, Mehta S. Noninvasive Ventilation in Patients With Hematologic Malignancy. J Intensive Care Med. 2017 Jan 1:885066617690725. doi: 10.1177/0885066617690725. Online ahead of print. |
| 30430851 | Background | MacEachern KN, Kraguljac AP, Mehta S. Nutrition Care of Critically Ill Patients with Leukemia: A Retrospective Study. Can J Diet Pract Res. 2019 Mar 1;80(1):34-38. doi: 10.3148/cjdpr-2018-033. Epub 2018 Nov 15. |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
| 8844239 | Background | Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available. |
| 8259894 | Background | Oczkowski WJ, Barreca S. The functional independence measure: its use to identify rehabilitation needs in stroke survivors. Arch Phys Med Rehabil. 1993 Dec;74(12):1291-4. doi: 10.1016/0003-9993(93)90081-k. |
| 9817683 | Background | Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086. |
| Background | Ware JE J, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Lincoln,R.I.: QualityMetric Inc.; 2002. |
| 16129869 | Background | Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. |
| 9051246 | Background | McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, Hurd DD. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997 Feb;19(4):357-68. doi: 10.1038/sj.bmt.1700672. |
| 11939242 | Background | Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002 Mar;21(2):271-92. doi: 10.1016/s0167-6296(01)00130-8. |
| 23204250 | Background | Ferguson ND, Scales DC, Pinto R, Wilcox ME, Cook DJ, Guyatt GH, Schunemann HJ, Marshall JC, Herridge MS, Meade MO; Canadian Critical Care Trials Group. Integrating mortality and morbidity outcomes: using quality-adjusted life years in critical care trials. Am J Respir Crit Care Med. 2013 Feb 1;187(3):256-61. doi: 10.1164/rccm.201206-1057OC. Epub 2012 Nov 29. |
| 19458562 | Background | Bender JM, Ampofo K, Gesteland P, Stoddard GJ, Nelson D, Byington CL, Pavia AT, Srivastava R. Development and validation of a risk score for predicting hospitalization in children with influenza virus infection. Pediatr Emerg Care. 2009 Jun;25(6):369-75. doi: 10.1097/PEC.0b013e3181a792a9. |
| 15122742 | Background | Sullivan LM, Massaro JM, D'Agostino RB Sr. Presentation of multivariate data for clinical use: The Framingham Study risk score functions. Stat Med. 2004 May 30;23(10):1631-60. doi: 10.1002/sim.1742. |
| 6878708 | Background | Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology. 1983 Sep;148(3):839-43. doi: 10.1148/radiology.148.3.6878708. |
| 12594312 | Background | Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450. |
| 21470008 | Background | Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. |