Lactate Clearance Goal-directed Therapy in Sepsis

NCT03256461 | Unknown DMC

• 1 other identifier: LCGRIS-01
• Study Type: interventional
• Target: 1,128
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; lactate clearance; protocolized resuscitation

Outcome Measures

Primary Outcomes (1)

• 28-d mortality

  All-cause mortality at 28 days

  Four years

Secondary Outcomes (8)

• ICU Length of stay

  Four years

• Hospital Length of stay

  Four years

• 90-d mortality

  Four years

• In-hospital mortality

  Four years

• In-ICU mortality

  Four years

Study Arms (3)

Lactate clearance 10% target group

EXPERIMENTAL

Lactate clearance falls by 10-percent every two hours.

Behavioral: Lactate clearance 10% target group

Lactate clearance 20% target group

EXPERIMENTAL

Lactate clearance falls by 20-percent every two hours.

Behavioral: Lactate clearance 20% target group

Standard EGDT group

PLACEBO COMPARATOR

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

Behavioral: Standard EGDT group

Interventions

Lactate clearance 10% target group BEHAVIORAL

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

Also known as: Lac% 10% group

Lactate clearance 10% target group

Lactate clearance 20% target group BEHAVIORAL

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

Also known as: Lac% 20% group

Lactate clearance 20% target group

Standard EGDT group BEHAVIORAL

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

Also known as: EGDT group

Standard EGDT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Lactase; Population Groups

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Demography; Population Characteristics

Study Officials

• Chen Zhongqing, Ph.D

  Southern Medical University

  STUDY CHAIR

Central Study Contacts

Chen Zhongqing, Ph.D

CONTACT

020-61641886; 13503049103@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 22, 2017
• Study Start: August 21, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)