Clinical trial NCT03214913: Controlled Fluid Resuscitation in Sepsis
Official title: Controlled Fluid Resuscitation Strategy in Sepsis Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Keywords: resuscitation
fluid therapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2017-07-12
Enrollment: 550
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mortality
timeFrame: the 28th day from enrolled
Secondary outcomes:
measure: Mortality
timeFrame: the 60th day from enrolled
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Zhen Er Chen
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.