Controlled Fluid Resuscitation in Sepsis

Controlled Fluid Resuscitation Strategy in Sepsis Patient

To evaluate two different strategy of fluid resuscitation in sepsis patients

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Other: Early Goal Directed Therapy; Other: Ruijin Strategy

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

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: EGDT 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; 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%.; Other Names: controlled fluid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	the 28th day from enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	the 60th day from enrolled

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Zhen Er Chen, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 8, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 8, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: resuscitation; fluid therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: Sepsis Fluid 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No