NCT03214913

Controlled Fluid Resuscitation in Sepsis

Controlled Fluid Resuscitation Strategy in Sepsis Patient

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sepsis

Interventions

Type	Name	Description
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	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%.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2017-07-12
• Last updated: 2017-07-12