Controlled Fluid Resuscitation in Sepsis

NCT03214913 | Unknown

• 1 other identifier: Sepsis Fluid 1
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate two different strategy of fluid resuscitation in sepsis patients

Conditions

Sepsis

Keywords

resuscitation; fluid therapy

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality

  the 28th day from enrolled

Secondary Outcomes (1)

• Mortality

  the 60th day from enrolled

Study Arms (2)

EGDT Group

OTHER

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

Ruijin Group

OTHER

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

Early Goal Directed Therapy OTHER

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

EGDT Group

Ruijin Strategy OTHER

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

Ruijin Group

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead
• RenJi Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Related Publications (4)

• 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.

  PMID: 19187641 BACKGROUND

• 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.

  PMID: 25272316 BACKGROUND

• 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.

  PMID: 16714767 BACKGROUND

• 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.

  PMID: 26903338 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Zhen Er Chen

  Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Qiang En Mao, Doctor

CONTACT

+86 18917762931; maoeq@yeah.net

Zhen Er Chen, Doctor

CONTACT

+86 18917762828; chenerzhen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: July 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share