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Lactate Clearance Goal-directed Therapy in Sepsis

Primary Purpose

Sepsis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lactate clearance 10% target group

Lactate clearance 20% target group

Standard EGDT group

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, lactate clearance, protocolized resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 17 years old.
Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).
Be transferred to intensive care unit (ICU) for the first time during this hospitalization.
Elevated lactate ≥3.0mmol/L.

Exclusion Criteria:

Acute hemorrhage uncontrolled.
Pregnancy.
Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.
Known being in an immunosuppressive state:
1. Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy.
2. Known human immunodeficiency virus (HIV) serology positive.
Known chronic kidney disease.
Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia.
Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week.
Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.

Sites / Locations

NanFang hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactate clearance 10% target group

Lactate clearance 20% target group

Standard EGDT group

Arm Description

Lactate clearance falls by 10-percent every two hours.

Lactate clearance falls by 20-percent every two hours.

Refer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation.

Outcomes

Primary Outcome Measures

28-d mortality

All-cause mortality at 28 days

Secondary Outcome Measures

ICU Length of stay

Length of stay in the intensive care unit (ICU)

Hospital Length of stay

Length of stay in hospital

90-d mortality

All-cause mortality at 90 days

In-hospital mortality

All-cause mortality during hospitalization

In-ICU mortality

All-cause mortality during ICU stay

Administered treatments

Administered treatments included: crystalloid volume, vasopressor administered, dobutamine, red blood cell(RBC) transfusion, mechanical ventilation, renal-replacement therapy

SOFA at 24h

Sequential Organ Failure Assessment(SOFA) at 24 hours

Adverse events

Proportion of patients reporting treatment-emergent adverse events

Full Information

NCT ID

NCT03256461

First Posted

August 7, 2017

Last Updated

August 21, 2017

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03256461

Brief Title

Lactate Clearance Goal-directed Therapy in Sepsis

Official Title

Multi-center Clinical Trial of Lactate Clearance Goal-directed Fluid Resuscitation in Patients With Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 21, 2017 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated "We suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion", with weak recommendation and low quality of evidence. Several trials which evaluated the resuscitation strategy included lactate clearance as a target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results. The aim of this study is to explore the feasibility of lactate clearance guide resuscitation in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic shock through multi-center, central-randomization clinical trial.

Detailed Description

Sepsis remains a great challenge for clinicians, early goal-directed therapy(EGDT), referring to a number of target-achieving indicators including systemic central venous oxygen saturation(ScvO2) after initial fluid resuscitation within 6 hours, has been one of the main treatment for sepsis. ScvO2 is the only indicator that reflects tissue oxygen metabolism. However, there're studies confirmed that ScvO2 oriented EGDT cannot reduce the mortality of sepsis. So it is important to find out a more effective indicator. Lactic acid is a product of anaerobic metabolism of the body, lactate clearance has been found to effectively predict the prognosis of sepsis. Few studies have shown that lactate clearance oriented fluid resuscitation can be of benefit in patients with sepsis. Nevertheless, whether lactate clearance could be combined with sepsis Bundle as a new marker to improve the prognosis remains a problem. The objective of this study is to discuss the feasibility of lactate clearance oriented sepsis treatment through multi-center clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

sepsis, lactate clearance, protocolized resuscitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This trial is a prospective, multicenter, single-blind, parallel-group, central-randomized, controlled trial

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactate clearance 10% target group

Arm Type

Experimental

Arm Description

Lactate clearance falls by 10-percent every two hours.

Arm Title

Lactate clearance 20% target group

Arm Type

Experimental

Arm Description

Lactate clearance falls by 20-percent every two hours.

Arm Title

Standard EGDT group

Arm Type

Placebo Comparator

Arm Description

Refer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation.

Intervention Type

Behavioral

Intervention Name(s)

Lactate clearance 10% target group

Other Intervention Name(s)

Lac% 10% group

Intervention Description

Participants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment.

Intervention Type

Behavioral

Intervention Name(s)

Lactate clearance 20% target group

Other Intervention Name(s)

Lac% 20% group

Intervention Description

Participants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment.

Intervention Type

Behavioral

Intervention Name(s)

Standard EGDT group

Other Intervention Name(s)

EGDT group

Intervention Description

Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.

Primary Outcome Measure Information:

Title

28-d mortality

Description

All-cause mortality at 28 days

Time Frame

Four years

Secondary Outcome Measure Information:

Title

ICU Length of stay

Description

Length of stay in the intensive care unit (ICU)

Time Frame

Four years

Title

Hospital Length of stay

Description

Length of stay in hospital

Time Frame

Four years

Title

90-d mortality

Description

All-cause mortality at 90 days

Time Frame

Four years

Title

In-hospital mortality

Description

All-cause mortality during hospitalization

Time Frame

Four years

Title

In-ICU mortality

Description

All-cause mortality during ICU stay

Time Frame

Four years

Title

Administered treatments

Description

Administered treatments included: crystalloid volume, vasopressor administered, dobutamine, red blood cell(RBC) transfusion, mechanical ventilation, renal-replacement therapy

Time Frame

Four years

Title

SOFA at 24h

Description

Sequential Organ Failure Assessment(SOFA) at 24 hours

Time Frame

Four years

Title

Adverse events

Description

Proportion of patients reporting treatment-emergent adverse events

Time Frame

Four years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Older than 17 years old. Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA). Be transferred to intensive care unit (ICU) for the first time during this hospitalization. Elevated lactate ≥3.0mmol/L. Exclusion Criteria: Acute hemorrhage uncontrolled. Pregnancy. Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension. Known being in an immunosuppressive state: Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy. Known human immunodeficiency virus (HIV) serology positive. Known chronic kidney disease. Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia. Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week. Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Zhongqing, Ph.D

Phone

020-61641886

13503049103@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Zhongqing, Ph.D

Organizational Affiliation

Southern Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

NanFang hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhongqing Chen, Ph.D

Phone

+86 20 6164 1886

13503049103@163.com

First Name & Middle Initial & Last Name & Degree

Yaoyuan Zhang, Master

m18620660446@163.com

First Name & Middle Initial & Last Name & Degree

Weijun Fu, Master

First Name & Middle Initial & Last Name & Degree

Xingui Dai, Master

First Name & Middle Initial & Last Name & Degree

Yaoyuan Zhang, Master

12. IPD Sharing Statement

Plan to Share IPD

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