Controlled Fluid Resuscitation in Sepsis

Sepsis Clinical Trial

Official title:

Controlled Fluid Resuscitation Strategy in Sepsis Patient

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03214913
• Other study ID #: Sepsis Fluid 1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 7, 2017
• Last updated: July 8, 2017
• Start date: January 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2017
• Source: Ruijin Hospital
• Contact: Qiang En Mao, Doctor
• Phone: +86 18917762931
• Email: maoeq[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate two different strategy of fluid resuscitation in sepsis patients

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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.
• 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%.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

References & Publications (4)

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. — View 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. — View 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. Epub 2006 May 21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality	the 28th day from enrolled
Secondary	Mortality	Mortality	the 60th day from enrolled