Controlled Fluid Resuscitation in Sepsis

Controlled Fluid Resuscitation Strategy in Sepsis Patient

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03214913

Enrollment

550

Registered

2017-07-12

Start date

2018-01-01

Completion date

2021-06-30

Last updated

2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

resuscitation, fluid therapy

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

Interventions

OTHEREarly 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.

OTHERRuijin 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%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

8 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	the 28th day from enrolled	Mortality

Secondary

Measure	Time frame	Description
Mortality	the 60th day from enrolled	Mortality

Contacts

Primary ContactQiang En Mao, Doctor

maoeq@yeah.net+86 18917762931

Backup ContactZhen Er Chen, Doctor

chenerzhen@hotmail.com+86 18917762828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026