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Status unknownNCT03214913Updated Jul 12, 2017

Controlled Fluid Resuscitation in Sepsis

An interventional study of Early Goal Directed Therapy and Ruijin Strategy in Sepsis, sponsored by Ruijin Hospital. Status unknown. Open to participants aged 8 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-12.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
8 Years to 80 Years
Sex
All
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Study summary

To evaluate two different strategy of fluid resuscitation in sepsis patients

Read the 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

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Conditions studied

  • Sepsis

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Keywords

  • resuscitation
  • fluid therapy
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In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 550 is above the median of 105 across 893 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
550 participants (estimated)

Study arms

  • Other
    EGDT Group

    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.

    Other: Early Goal Directed Therapy

  • Other
    Ruijin Group

    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%.

    Other: Ruijin Strategy

Interventions

  • OtherEarly Goal Directed Therapy

    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.

    Also known as: EGDT therapy

  • OtherRuijin Strategy

    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%.

    Also known as: controlled fluid therapy

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What researchers measure

Primary outcomes

  1. Mortality

    Mortality

    Time frame: the 28th day from enrolled

Secondary outcomes

  1. Mortality

    Mortality

    Time frame: the 60th day from enrolled

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19187641 ↗
  • 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. PubMed 25272316 ↗
  • 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. PubMed 16714767 ↗
  • 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. PubMed 26903338 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03214913
Lead sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Erzhen Chen (Professor, Ruijin Hospital) — Principal investigator
First posted
Jul 12, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Jul 12, 2017

Study contacts

Qiang En Mao, Doctor
Contact
maoeq@yeah.net
+86 18917762931
Zhen Er Chen, Doctor
Contact
chenerzhen@hotmail.com
+86 18917762828
Zhen Er Chen
study director · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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