Controlled Fluid Resuscitation in Sepsis

Study Overview
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Brief Summary
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To evaluate two different strategy of fluid resuscitation in sepsis patients

Detailed Description
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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

Official Title
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Controlled Fluid Resuscitation Strategy in Sepsis Patient

Conditions
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Sepsis

Intervention / Treatment
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* Other: Early Goal Directed Therapy
* Other: Ruijin Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EGDT Group<br>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<br>* 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.<br>* Other names: EGDT therapy;|
| Other: Ruijin Group<br>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<br>* 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%.<br>* Other names: controlled fluid therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resuscitation, fluid therapy