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Controlled Fluid Resuscitation in Sepsis

Primary Purpose

Sepsis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Goal Directed Therapy
Ruijin Strategy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring resuscitation, fluid therapy

Eligibility Criteria

8 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline,due to infection )
  • 2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP<90mmHg after 20ml/kg fluid bolus
  • 3.the shock is diagnosed within 24hrs after onset

Exclusion Criteria:

  • - 1.<18 years old
  • 2.Pregnancy
  • 3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome
  • 4 with contra-indication of CVC(central venous catheter) placement
  • 5 trauma or major burn
  • 6 poisoning
  • 7 any cancer receiving chemotherapy
  • 8.immunosuppression (for organ transplantation or disease of immune system)
  • 9.acute pancreatitis
  • 10.relapse sepsis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    EGDT Group

    Ruijin Group

    Arm Description

    Early Goal Directed Therapy :30ml/kg in the first bolus to have a CVP(central venous pressure) 8-12 mmHg and MAP(mean artery pressure ) 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenaline,red blood cell transfusion if necessary.

    Ruijin Strategy therapy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary. target: fulfillment of two or more of four criteria:1. HR(heart rate) <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT(hematocrit) 25%~35%.

    Outcomes

    Primary Outcome Measures

    Mortality
    Mortality

    Secondary Outcome Measures

    Mortality
    Mortality

    Full Information

    First Posted
    July 7, 2017
    Last Updated
    July 8, 2017
    Sponsor
    Ruijin Hospital
    Collaborators
    RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03214913
    Brief Title
    Controlled Fluid Resuscitation in Sepsis
    Official Title
    Controlled Fluid Resuscitation Strategy in Sepsis Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruijin Hospital
    Collaborators
    RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate two different strategy of fluid resuscitation in sepsis patients
    Detailed Description
    Early goal-directed fluid therapy (EGDT) had been regarded as an important fluid therapy strategy in early sepsis or septic shock patients. In recent years, several randomized control studies showed the EGDT therapy cannot make a better outcome in sepsis patients compared to the standard therapy. A strategy of controlled fluid resuscitation had showed good outcome in critical illness such as severe acute pancreatitis, major trauma. But many aspects of the so-called controlled fluid resuscitation remained controversial. In a previous study on severe acute pancreatitis, we described a bundle of controlled fluid resuscitation which had showed an ideal result with higher survival rate. So, we are going to use the bundle on sepsis patients, and to see if it can bring a better out come in sepsis patients compared to the EGDT strategy. This study aims to determine a better strategy of fluid resuscitation in sepsis patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis
    Keywords
    resuscitation, fluid therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    550 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EGDT Group
    Arm Type
    Other
    Arm Description
    Early Goal Directed Therapy :30ml/kg in the first bolus to have a CVP(central venous pressure) 8-12 mmHg and MAP(mean artery pressure ) 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenaline,red blood cell transfusion if necessary.
    Arm Title
    Ruijin Group
    Arm Type
    Other
    Arm Description
    Ruijin Strategy therapy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary. target: fulfillment of two or more of four criteria:1. HR(heart rate) <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT(hematocrit) 25%~35%.
    Intervention Type
    Other
    Intervention Name(s)
    Early Goal Directed Therapy
    Other Intervention Name(s)
    EGDT therapy
    Intervention Description
    EGDT therapy :30ml/kg in the first bolus to have a CVP 8-12 mmHg and MAP 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%;If not, use noradrenine,red blood cell transfusion if necessary.
    Intervention Type
    Other
    Intervention Name(s)
    Ruijin Strategy
    Other Intervention Name(s)
    controlled fluid therapy
    Intervention Description
    Ruijin Strategy:10~5ml/kg/h,crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary. target: fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT 25%~35%.
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    Mortality
    Time Frame
    the 28th day from enrolled
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Mortality
    Time Frame
    the 60th day from enrolled

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline,due to infection ) 2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP<90mmHg after 20ml/kg fluid bolus 3.the shock is diagnosed within 24hrs after onset Exclusion Criteria: - 1.<18 years old 2.Pregnancy 3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome 4 with contra-indication of CVC(central venous catheter) placement 5 trauma or major burn 6 poisoning 7 any cancer receiving chemotherapy 8.immunosuppression (for organ transplantation or disease of immune system) 9.acute pancreatitis 10.relapse sepsis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiang En Mao, Doctor
    Phone
    +86 18917762931
    Email
    maoeq@yeah.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhen Er Chen, Doctor
    Phone
    +86 18917762828
    Email
    chenerzhen@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhen Er Chen
    Organizational Affiliation
    Shanghai Jiao Tong University School of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19187641
    Citation
    Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.
    Results Reference
    background
    PubMed Identifier
    25272316
    Citation
    ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
    Results Reference
    background
    PubMed Identifier
    16714767
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26903338
    Citation
    Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
    Results Reference
    background

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    Controlled Fluid Resuscitation in Sepsis

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