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Dexamethasone Treatment for Sepsis-associated Acute Respiratory Distress Syndrome: a Multicenter, Randomised, Double-blinded, Controlled Trial (DEFEND)

2026년 8월 31일 업데이트: Jianfeng Xie, Southeast University, China

Acute respiratory distress syndrome (ARDS) is a major cause of acute hypoxemic respiratory failure in critically ill patients and is associated with substantial mortality. Current management is largely supportive, and no pharmacologic therapy has been shown consistently to reduce mortality in a broad population of patients with ARDS. Inflammation plays a central role in the pathogenesis of ARDS. Excessive inflammatory activation contributes to alveolar-capillary injury, impaired gas exchange, and progression of organ dysfunction. Glucocorticoids may mitigate these processes and have been associated in some studies with improved clinical outcomes, including shorter duration of mechanical ventilation. However, the effect of glucocorticoids on survival remains uncertain.

ARDS is a heterogeneous syndrome with diverse etiologies, and treatment response may vary according to the underlying cause. A post hoc analysis of the Dex-ARDS trial suggested that the treatment effect of glucocorticoids may be greater in ARDS caused by pneumonia or extrapulmonary sepsis. In a cross-sectional survey of 135 patients with ARDS from 20 ICUs in China, pneumonia- and extrapulmonary sepsis-associated ARDS accounted for 77.6% of cases, indicating that these are the predominant etiologic subtypes encountered in clinical practice in China. More importantly, compared with ARDS attributable to other causes, pneumonia- and extrapulmonary sepsis-associated ARDS has been associated with higher mortality, suggesting a greater disease burden, worse prognosis, and a more urgent need for improved treatment strategies. On this basis, the present trial will enroll patients with ARDS caused by sepsis, including pneumonia and extrapulmonary sepsis.

The primary hypothesis of this study is that, among patients with sepsis-associated ARDS, dexamethasone plus usual care, as compared with placebo plus usual care, will reduce 90-day all-cause mortality. We therefore designed a multicenter, randomized, double-blind, controlled trial to evaluate the clinical efficacy of dexamethasone in patients with sepsis-associated ARDS. The primary objective is to compare dexamethasone plus usual care with placebo plus usual care with respect to 90-day all-cause mortality.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1704

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
      • Nanjing, 중국
        • 모병
        • Zhongda Hospital, School of Medicine, Southeast University
        • 연락하다:
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210009
        • 아직 모집하지 않음
        • Zhongda Hospital, School of Medicine, Southeast University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age 18 years or older
  2. Suspected or confirmed infection
  3. Receipt of invasive mechanical ventilation with a positive end-expiratory pressure (PEEP) of at least 5 cm H₂O, noninvasive positive-pressure ventilation with a PEEP of at least 5 cm H₂O, or high-flow nasal oxygen therapy with a flow rate of at least 30 L/min
  4. Acute-onset ARDS, defined as ARDS diagnosed for at least 6 hours but no more than 72 hours, according to the following criteria:

(1) New or worsening respiratory symptoms or respiratory failure (2) Pulmonary infiltrates on chest radiography or computed tomography, or B-lines or consolidation on lung ultrasonography, not fully explained by pleural effusion, lobar or whole-lung collapse or atelectasis, or pulmonary nodules. Patients with unilateral pulmonary infiltrates, B-lines, or consolidation are eligible (3) Respiratory failure not fully explained by cardiac failure or fluid overload (4) Hypoxemia defined as PaO₂/FiO₂ of 300 mm Hg or less, or SpO₂/FiO₂ of 315 or less, with SpO₂ no greater than 97%.

Exclusion Criteria:

  1. Pregnancy
  2. Planned withdrawal of life-sustaining treatment within the next 24 hours
  3. Current hospitalization for more than 7 days before screening;
  4. Clinical improvement within the 48 hours before randomization, based on the investigator's overall assessment
  5. Highly suspected or confirmed COVID-19 infection
  6. Severe chronic obstructive pulmonary disease, defined as a PaCO₂ ≥ 60 mmHg in a stable condition, or the need for long-term oxygen therapy, excluding CPAP/BiPAP prescribed exclusively for sleep-disordered breathing.
  7. Congestive heart failure (NYHA III-IV)
  8. A definite clinical indication for high-dose corticosteroids at screening, defined as a maximum daily dose exceeding hydrocortisone 200 mg or an equivalent glucocorticoid dose
  9. Contraindications to short-term dexamethasone, including untreated systemic fungal infection, active tuberculosis, active viral hepatitis, or major upper gastrointestinal bleeding
  10. Known hypersensitivity to dexamethasone
  11. Participation in another interventional clinical trial within the previous 30 days

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dexamethasone Group
Dexamethasone plus usual care
의약품: Dexamethasone
Participants assigned to dexamethasone will receive 20 mg intravenously as soon as possible after randomization. Beginning after 10:00 am on the next calendar day following randomization, dexamethasone 20 mg will be administered once daily through day 5, followed by dexamethasone 10 mg once daily from Day 6 to Day 10.
다른 이름들:
  • Dexamethasone sodium phosphate injection, 5 mg/1 mL
위약 비교기: Placebo Group
Placebo plus usual care
의약품: Placebo
Participants assigned to the placebo group will receive 0.9% sodium chloride injection as matching placebo, administered according to the same schedule as dexamethasone

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
90-day all-cause mortality
기간: From randomization (day 0) to day 90 (inclusive)
The proportion of participants who die from any cause between randomization (day 0) and day 90 (inclusive)
From randomization (day 0) to day 90 (inclusive)

2차 결과 측정

결과 측정
측정값 설명
기간
Ventilator-free days through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The number of days from randomization (day 0) to day 28 (inclusive) during which the patient is alive and successfully liberated from invasive mechanical ventilation
From randomization (day 0) to day 28 (inclusive)
Vasopressor-free days through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The number of days from randomization (day 0) to day 28 (inclusive) during which the patient is alive and successfully discontinued from vasopressor therapy
From randomization (day 0) to day 28 (inclusive)
Renal replacement therapy-free days through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The number of days from randomization (day 0) to day 28 (inclusive) during which the patient is alive and does not require renal replacement therapy
From randomization (day 0) to day 28 (inclusive)
28-day all-cause mortality
기간: From randomization (day 0) to day 28 (inclusive)
The proportion of participants who die from any cause between randomization (day 0) and day 28 (inclusive)
From randomization (day 0) to day 28 (inclusive)
In-hospital mortality
기간: Time Frame: From randomization (day 0) up to hospital discharge, assessed up to 90 days
The proportion of participants who die from any cause between randomization (day 0) and hospital discharge (inclusive). If a patient remains hospitalized for more than 90 days, 90-day mortality will be used as in-hospital mortality
Time Frame: From randomization (day 0) up to hospital discharge, assessed up to 90 days
6-month all-cause mortality
기간: From randomization (day 0) to 6 months (inclusive)
The proportion of participants who die from any cause between randomization (day 0) and 6 months (inclusive)
From randomization (day 0) to 6 months (inclusive)
12-month all-cause mortality
기간: From randomization(day 0) to 12 months
The proportion of participants who die from any cause between randomization (day 0) and 12 months
From randomization(day 0) to 12 months
Decision to withhold or withdraw active treatment during hospitalization
기간: Time Frame: From randomization (day 0) up to hospital discharge, assessed up to 90 days
The proportion of participants in whom active treatment is withheld or withdrawn between randomization (day 0) and hospital discharge (inclusive)
Time Frame: From randomization (day 0) up to hospital discharge, assessed up to 90 days
Telephone Interview for Cognitive Status-Modified (TICS-m)
기간: 90 days, 6 months and 12 months after randomization
Cognitive status was assessed using a Chinese modified version of the Telephone Interview for Cognitive Status-modified (TICS-m). Higher scores indicate better cognitive performance
90 days, 6 months and 12 months after randomization
Post-Traumatic Stress Disorder (PTSD)
기간: 90 days, 6 months and 12 months after randomization
Psychological outcomes will be assessed with the Post-traumatic Stress Disorder Checklist-Civilian Version (PCL-C, Chinese version). Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point scale, with higher scores indicating more severe levels of PTSD.
90 days, 6 months and 12 months after randomization
Health-related quality of life (EQ-5D-5L)
기간: 90 days, 6 months and 12 months after randomization
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument at 90 days, 6months and 12 months after randomization. The EQ-5D-5L measures health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
90 days, 6 months and 12 months after randomization
Functional Activities Questionnaire (FAQ)
기간: 90 days, 6 months, 12 months after randomization
Caregiver-reported outcome, higher scores indicating worse impairment.
90 days, 6 months, 12 months after randomization
Activities of daily living (ADL) score
기간: 90 days, 6 months, 12 months after randomization
Assessed using the Barthel Index, including feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair/bed transfer, ambulation, and stair climbing, higher scores indicate greater independence.
90 days, 6 months, 12 months after randomization
Hospital-free days through day 90
기간: From randomization (day 0) to day 90 (inclusive)
The number of days from randomization (day 0) to day 90 (inclusive) during which the patient is alive and does not require hospitalization
From randomization (day 0) to day 90 (inclusive)

기타 결과 측정

결과 측정
측정값 설명
기간
Incidence of weaning success through day 28
기간: From randomization (day 0) to day 28 (inclusive)

For intubated patients, successful weaning was defined as survival without reintubation within 7 days after extubation, or liberation from invasive mechanical ventilation with ICU discharge within 7 days.

For tracheostomized patients, successful weaning was defined as spontaneous breathing via tracheostomy without mechanical ventilation for at least 7 consecutive days, or liberation from invasive mechanical ventilation with ICU discharge within 7 days.

Reintubation for diagnostic purposes (e.g., bronchoscopy) or planned surgical procedures (e.g., wound debridement, abdominal lavage, internal fixation of fractures, tracheostomy) was not considered weaning failure.
From randomization (day 0) to day 28 (inclusive)
Incidence of gastrointestinal bleeding through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The proportion of participants who developed acute gastrointestinal bleeding requiring transfusion of more than 1 unit of packed red blood cells within 24 hours
From randomization (day 0) to day 28 (inclusive)
Incidence of secondary bloodstream infection through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The proportion of participants who developed secondary bloodstream infection through day 28
From randomization (day 0) to day 28 (inclusive)
Incidence of VAP through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The proportion of participants who developed ventilator-associated pneumonia through day 28
From randomization (day 0) to day 28 (inclusive)
Incidence of hyperglycemia events through day 28
기간: From randomization (day 0) to day 28 (inclusive)
The proportion of participants who had hyperglycemia events (blood glucose level >180 mg/dl) through day 28
From randomization (day 0) to day 28 (inclusive)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Southeast University, China

수사관

  • 수석 연구원: Jianfeng Xie, MD, Southeast University, Zhongda Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • [1] MATTHAY M A, ARABI Y, ARROLIGA A C, et al. A New Global Definition of Acute Respiratory Distress Syndrome[J]. American Journal of Respiratory and Critical Care Medicine, 2024, 209(1): 37-47. [2] BELLANI G, LAFFEY J G, PHAM T, et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries[J]. JAMA, 2016, 315(8): 788. [3] LIU L, YANG Y, GAO Z, et al. Practice of diagnosis and management of acute respiratory distress syndrome in mainland China: a cross-sectional study[J]. Journal of Thoracic Disease, 2018, 10(9): 5394-5404. [4] MATTHAY M A, ZEMANS R L, ZIMMERMAN G A, et al. Acute respiratory distress syndrome[J]. Nature Reviews Disease Primers, 2019, 5(1): 18. [5] MEDURI G U, GOLDEN E, FREIRE A X, et al. Methylprednisolone infusion in early severe ARDS[J]. Chest, 2007, 131(4): 954-963. [6] ANNANE D, SÉBILLE V, BELLISSANT E. Effect of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome*:[J]. Critical Care Medicine, 2006, 34(1): 22-30. [7] TONGYOO S, PERMPIKUL C, MONGKOLPUN W, et al. Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: Results of a randomized controlled trial[J]. Critical Care, 2016, 20(1): 329. [8] GRASSELLI G, CALFEE C S, CAMPOROTA L, et al. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies[J]. Intensive Care Medicine, 2023, 49(7): 727-759. [9] VILLAR J, FERRANDO C, MARTÍNEZ D, et al. Dexamethasone treatment for the acute respiratory distress syndrome: A multicentre, randomised controlled trial[J]. The Lancet Respiratory Medicine, 2020, 8(3): 267-276. [10] CHRIGUER R S, ROSELINO A M, DE CASTRO M. Glucocorticoid sensitivity and proinflammatory cytokines pattern in pemphigus[J]. Journal of Clinical Immunology, 2012, 32(4): 786-793.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 27일

기본 완료 (추정된)

2029년 9월 30일

연구 완료 (추정된)

2030년 9월 30일

연구 등록 날짜

최초 제출

2026년 4월 25일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 31일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DEFEND Trial

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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