Controlled Fluid Resuscitation in Sepsis

Not Applicable

• Conditions: Sepsis
• Interventions: Other: Early Goal Directed Therapy; Other: Ruijin Strategy

• Registration Number: NCT03214913
• Lead Sponsor: Ruijin Hospital

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

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-08
• Last Update Submitted: 2017-07-08
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12
• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGDT Group	Early Goal Directed Therapy	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.
Ruijin Group	Ruijin Strategy	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%.

Primary Outcome Measures

Name	Time	Method
Mortality	the 28th day from enrolled	Mortality

Secondary Outcome Measures

Name	Time	Method
Mortality	the 60th day from enrolled	Mortality