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

NCT02566460 | Completed

• 1 other identifier: PUMCH-S616
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Lactate clearance; systemic central venous oxygen saturation; septic shock; haemodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 60-day mortality

  60 days

Secondary Outcomes (3)

• ventilator-free days

  60 days

• organs dysfunction/failure

  60 days

• the adverse events of the treatment

  60 days

Study Arms (2)

lactate clearance group

EXPERIMENTAL

Refer to lactate clearance rate to perform resuscitation therapy

Other: Resuscitation

SCVO2 group

SHAM COMPARATOR

Refer to SCVO2 to perform resuscitation therapy

Other: Resuscitation

Interventions

Resuscitation OTHER

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.

SCVO2 group; lactate clearance group

Eligibility Criteria

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

You may qualify if:

• Refractory hypotension was defined as a systolic blood pressure lower than 90 mm Hg, or a mean arterial pressure of less than 65 mm Hg , after an intravenous fluid challenge of 20 ml or more per kilogram of body weight.
• Patients had to be enrolled in the study within 2 hours after the earliest detection of septic shock and within 12 hours after arrival ICU.

You may not qualify if:

• The patients were excluded if they meet any one of follows: an age of less than 18 years, pregnancy, an acute cerebral vascular event (Glasgow coma score \< 5), acute myocardial infarction or acute coronary syndrome, massive pulmonary embolism, status asthmaticus, a primary diagnosed cardiac dysrhythmias, contraindication to central venous catheterization, active gastrointestinal hemorrhage, massive intra abdominal infective focus without drainage, severe bronchopleural fistula, seizure, during chemotherapy or immunosuppressive therapy, or end stage of the diseases.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (1)

• Zhou X, Liu D, Su L, Yao B, Long Y, Wang X, Chai W, Cui N, Wang H, Rui X. Use of stepwise lactate kinetics-oriented hemodynamic therapy could improve the clinical outcomes of patients with sepsis-associated hyperlactatemia. Crit Care. 2017 Feb 16;21(1):33. doi: 10.1186/s13054-017-1617-1.

  PMID: 28202033 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: September 26, 2015
• First Posted: October 2, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: May 3, 2016

Record last verified: 2016-02