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The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock

NCT02566460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2016-05-03

No results posted yet for this study

Summary

The purpose of this study is to explore and assess possible outcome benefits of lactate clearance\>30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during early resuscitation of septic shock through a single-center randomized controlled study. The investigators anticipate to collect 300-400 qualified patients with septic shock who were selected from critically ill patients admitted to the Department of Critical Care Medicine. The participants can be randomized divided into lactate clearance group and SCVO2 group. The investigators compared the treatment and the relevant parameters changed after different target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new emerged organ failure were collected and compared. 28-day survival curves were drew between these two group. And the adverse events of the treatment have also been compared. Through this study, the investigators want to answer that whether lactate clearance-oriented therapy can reduce the mortality in patients with septic shock, compared with ScvO2-oriented protocolised therapy.

Conditions

  • Septic Shock

Interventions

OTHER

Resuscitation

First, either crystalloid or colloid could be given to achieve a CVP of 8 to 12 mm Hg. Second, if the mean arterial pressure (MAP) was less than 65 mm Hg, norepinephrine was administrated to maintain MAP ≥65 mm Hg. If the mean arterial pressure was higher than 90 mm Hg, vasodilators were given until it was 90 mm Hg or below. Finally, SCVO2 or lactate clearance will be checked to determine red blood cells transfused or not to achieve a haematocrit of at least 30%. If ScvO2 or lactate clearance remains unmet target value, dobutamine could be used in the treatment.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566460 on ClinicalTrials.gov