Lactate Clearance Goal-directed Therapy in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256461
• Other study ID #: LCGRIS-01
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 21, 2017
• Start date: August 21, 2017
• Est. completion date: December 2021

Study information

• Verified date: August 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Chen Zhongqing, Ph.D
• Phone: 020-61641886
• Email: 13503049103[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1128
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Behavioral:
• Lactate clearance 10% target group
Participants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment.
• Lactate clearance 20% target group
Participants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment.
• Standard EGDT group
Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.

Locations

Country	Name	City	State
China	NanFang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-d mortality	All-cause mortality at 28 days	Four years
Secondary	ICU Length of stay	Length of stay in the intensive care unit (ICU)	Four years
Secondary	Hospital Length of stay	Length of stay in hospital	Four years
Secondary	90-d mortality	All-cause mortality at 90 days	Four years
Secondary	In-hospital mortality	All-cause mortality during hospitalization	Four years
Secondary	In-ICU mortality	All-cause mortality during ICU stay	Four years
Secondary	Administered treatments	Administered treatments included: crystalloid volume, vasopressor administered, dobutamine, red blood cell(RBC) transfusion, mechanical ventilation, renal-replacement therapy	Four years
Secondary	SOFA at 24h	Sequential Organ Failure Assessment(SOFA) at 24 hours	Four years
Secondary	Adverse events	Proportion of patients reporting treatment-emergent adverse events	Four years