NCT03256461

Lactate Clearance Goal-directed Therapy in Sepsis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,128 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.
BEHAVIORAL	Standard EGDT group	Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.

Timeline

• Start date: 2017-08-21
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2017-08-22
• Last updated: 2017-08-22

Locations

1 site across 1 country: China