Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure (CAREHEMA)
Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure: Impact on Prognosis: A Monocentric Observational Before-after Study
Over the last two decades, the number of patients with hematological malignancies (HMs) admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs increasingly require admission to the intensive care unit (ICU) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. Whether the increase in ICU admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. The criteria used for ICU referral and admission decisions have not been extensively evaluated. Finally, the links between admission policies and treatment-limitation decisions are unclear, but ICUs with broad admission policies may change the treatment goals based on the response to several days of full-code management.
The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of HMs patients presenting with acute respiratory and/or hemodynamic failure.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Grenoble, 프랑스
- Hematologic unit - Hospital Grenoble Alpes
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Grenoble, 프랑스
- Intensive Care Unit - Hospital Grenoble-Alpes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients hospitalized in a hematology unit
Patients presenting with criteria for critical respiratory and/or hemodynamic condition and worsening during the next 4 hours
- Respiratory : oxygen saturation <90 % and/or O2 >3l/min, with either a worsening of saturation or increased oxygen needs within 4h
- Hemodynamic : systolic blood pressure < 90 mmHg and remaining < 90 mmHg within 4h despite ≥ 1l of crystalloid administration, or becoming < 80 mmHg no matter the quantity of fluid (even if no fluid administration).
Exclusion Criteria:
- therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...)
- Do-not-reanimate directives
- Pregnant or breastfeeding women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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"Before phase"
Retrospective study of ICU admissions of hematology patients for respiratory and hemodynamic reasons Time period: January 2012 to March 2017
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"After Phase": Systematic evaluation by an intensivist
Corresponding to the period after the implementation of a systematic intensivist evaluation Daily screening of systolic blood pressure, oxygen saturation and oxygen requirements of all patients hospitalized in hematology wards. Systematic evaluation of any patient presenting the inclusion criteria by an intensivist and collegial care planning. Time period: From March 2017 to end of study |
implementation of a standardized procedure for patient care in ICU
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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delta Sepsis-related Organ Failure Assessment (SOFA) score
기간: up to 72 hours
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difference between the Sepsis-related Organ Failure Assessment score between 48h and 72h after ICU admission and the SOFA score during the first 24h. SOFA score ranges from 0 to 20 delta SOFA= SOFA day 3 - SOFA day1 |
up to 72 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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survival status after one year
기간: one year after ICU admission
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survival status (alive/dead) at one year after ICU admission
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one year after ICU admission
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survival status at the end of the ICU stage
기간: up to Day 45
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survival status (alive/dead) at the end of the ICU stage
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up to Day 45
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survival status at the end of the hospitalization
기간: up to Day 120
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survival status (alive/dead) at the end of the hospitalization
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up to Day 120
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ICU admission
기간: up to 72h
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Delay between the start of critical care illness and ICU admission Delay is measured in minutes
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up to 72h
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Invasive mechanical ventilation
기간: up to Day 45
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Number of days with mechanical ventilation
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up to Day 45
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Non-invasive ventilation
기간: up to Day 45
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Number of days with non-invasive ventilation
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up to Day 45
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Vasopressive support
기간: up to Day 45
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Number of days with vasopressive support
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up to Day 45
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renal replacement therapy
기간: up to Day 45
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Number of days with renal replacement therapy
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up to Day 45
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hematological disease evolution
기간: up to one year
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status of hematological primary disease at death or after one year of evolution if the patient is still alive.
Possible status of hematology disease : complete remission, partial remission, stability, relapsed/refractory.
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up to one year
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Life quality for patients
기간: up to one year
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EQ5-D assessment of patients' quality of life one year after Intensive care unit admission
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up to one year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nicolas Terzi, Chu Grenoble Alpes
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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