이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)

2022년 3월 24일 업데이트: Marie Kristine Jessen, MD

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)

This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis allocated to two different IV fluid regimens enrolled at three emergency departments in Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume within 24 hours and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day mortality.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

BACKGROUND:

Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.

OBJECTIVES:

The aim of the REFACED Sepsis trial is to test if an IV fluid restrictive protocol in ED patients with sepsis is feasible, i.e., if the protocol decreases the IV fluid volumes administered.

DESIGN:

REFACED Sepsis is a multicenter, randomized, parallel-group, open-labeled, feasibility trial

POPULATION:

ED patients with sepsis expected to be admitted for ≥ 24 hours

EXPERIMENTAL INTERVENTION:

In the IV fluid restriction group no IV fluids should be given unless one of the below mentioned occurs;

A fluid bolus of 250 ml isotonic crystalloid may be given within 15 minutes if one of the following occurs (hypoperfusion criteria):

  • Lactate concentration ≥ 4 mmol/l (arterial or venous blood gas/blood sample)
  • Hypotension (systolic BP < 90 mmHg)
  • Mottling beyond edge of kneecap (i.e., Mottling score >2)53
  • Severe oliguria, i.e., diuresis < 0.1 ml/kg/h, during the first 4 hours of admission

All patients will be ensured min. 1 L of oral/intravenous fluids in 24 hours and electrolytes can be corrected.

CONTROL INTERVENTION:

In the usual care group there will be no upper limit for the use of IV fluids.

OUTCOMES:

The primary outcome is 24-hour intravenous crystalloid fluid administration. Key secondary outcomes are: Feasibility measures: Number of patients with major protocol violations, Number of patients screened vs included, Time from admission to inclusion, Number of patients lost to follow up in terms of 24-hour fluids, Accumulated serious adverse reactions and events (SAEs + Suspected Unexpected Serious Adverse Reaction (SUSARs)) within 48 hours in-hospital, Total fluids (oral and intravenous) at 24 hours,

TRIAL-SIZE:

124 patients will be randomized to restrictive fluid administration or usual care within 24 hours of randomization

연구 유형

중재적

등록 (실제)

124

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 덴마크
    • Central Denmark Region
      • Aarhus, Central Denmark Region, 덴마크, 8200
        • Department of Emergency Medicine, Aarhus University Hospital
      • Randers, Central Denmark Region, 덴마크, 8930
        • Department of Emergency Medicine, Regional Hospital Randers
      • Viborg, Central Denmark Region, 덴마크, 8800
        • Department of Emergency Medicine, Regional Hospital Viborg

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria: All of the below must be fulfilled:

  1. Unplanned emergency department admission
  2. Age ≥ 18 years

  3. Sepsis defined as

    1. suspected infection by the treating clinician AND
    2. blood cultures drawn AND
    3. IV antibiotics administered or planned AND
    4. An infection related increase of SOFA*-score ≥ 2 from baseline

  4. Expected hospital stay > 24 hours as deemed by treating clinician

    • Sequential Organ Failure Assessment (SOFA) Score

Further more the patient must fulfill criteria for enrollment in an acute study according to Danish law

Exclusion Criteria: We will exclude patients fulfilling any of following exclusion criteria:

  1. ≥ 500 ml of fluids given prior to randomization
  2. Invasively ventilated or vasopressors initiated at the time of screening
  3. Known or suspected severe bleeding judged by the treating clinician
  4. Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
  5. Prior enrollment in the trial
  6. Patients, who the clinician expect not to survive the next 24-hours

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Restrictive fluid administration

No IV fluids unless one of the extenuating circumstances occur;

  1. In case of severe hypoperfusion or severe circulatory impairment defined by either: 1) Lactate≥4 mmol/L, 2) Hypotension (systolic BP < 90 mmHg), 3) Mottling beyond the kneecap (mottling score >2) OR 4) Urinary output<0.1 mL/kg bodyweight/h (only in the first 4hrs after randomization) then a bolus of 250 ml of IV crystalloid solution may be given followed by re-evaluation
  2. In case of overt fluid losses (e.g. vomiting, large aspirates,) IV fluid may be given to correct for the loss, but not above the volume lost.

  3. In case the oral/enteral route for water or electrolyte solutions is contraindicated or has failed, IV fluids may be given to:

    Correct dehydration or electrolyte deficiencies Ensure a total fluid input of 1 L in 24hrs

  4. IV fluids may be given as carrier for medication, but with lowest possible volume
의약품: Isotonic crystalloids

Types of fluids in both intervention groups:

  • Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
  • Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
  • Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.
활성 비교기: Usual care (standard care)

There will be no upper limit for the use of either IV or oral/enteral fluids

  1. IV fluids should be given in the case of hypoperfusion or circulatory impairment and should be continued as long as hemodynamic variables improve including static or dynamic variable(s) as chosen by the clinicians. These criteria are based on the Surviving Sepsis Campaign guideline.
  2. IV fluids should be given as maintenance if the ICU has a protocol recommending maintenance fluid
  3. IV fluids should be given to substitute expected or observed loss, dehydration or electrolyte derangements
의약품: Isotonic crystalloids

Types of fluids in both intervention groups:

  • Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
  • Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
  • Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
24-hour crystalloid iv. fluids
기간: 24 hours from randomization
total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization
24 hours from randomization

2차 결과 측정

결과 측정
측정값 설명
기간
Protocol violations
기간: 24 hours from randomization
Feasibility measure: Number of patients with major protocol violations
24 hours from randomization
Screened-vs.-randomized-ratio
기간: Through study completion, an average of 1 year
Feasibility measure: Number of patients screened vs included
Through study completion, an average of 1 year
Time to inclusion
기간: Through study completion, an average of 1 year
Feasibility measure: Time from admission to inclusion/randomization (hours)
Through study completion, an average of 1 year
Lost-to-follow-up-rate
기간: 24 hours from randomization
Feasibility measure: Number of patients lost to follow up in terms of 24-hour fluids
24 hours from randomization
Accumulated serious adverse reactions (SARs + SUSARs)
기간: 7 days from randomization
Feasibility measure: Accumulated serious adverse reactions and events (SAEs + SARs+ SUSARs) within 7 days in-hospital
7 days from randomization
Total 24-hour fluids
기간: 24 hours from randomization
Total fluids (oral and intravenous) at 24 hours
24 hours from randomization
Mortality
기간: Total of 90-days
In-hospital, 30- and 90-days mortality
Total of 90-days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Marie Kristine Jessen, MD

협력자

Aarhus University Hospital
University of Aarhus
Viborg Regional Hospital
Randers Regional Hospital

수사관

  • 수석 연구원: Marie K Jessen, MD, Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Denmark

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

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)

2021년 11월 3일

기본 완료 (실제)

2021년 12월 19일

연구 완료 (실제)

2022년 3월 19일

연구 등록 날짜

최초 제출

2021년 9월 11일

QC 기준을 충족하는 최초 제출

2021년 9월 30일

처음 게시됨 (실제)

2021년 10월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 24일

마지막으로 확인됨

2022년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RECEM0001
  • 2021-000224-35 (EudraCT 번호)
  • 1-10-72-163-21 (기타 식별자: The Committee on Health Research Ethics, Central Denmark Region)

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. .

Isotonic crystalloids에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Ethiopia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다