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

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ClinicalTrials.gov Identifier: NCT02566460
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Septic Shock Other: Resuscitation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2013
Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: lactate clearance group
Refer to lactate clearance rate to perform resuscitation therapy
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.
Sham Comparator: SCVO2 group
Refer to SCVO2 to perform resuscitation therapy
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.


Outcome Measures

Primary Outcome Measures :
  1. 60-day mortality [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. ventilator-free days [ Time Frame: 60 days ]
  2. organs dysfunction/failure [ Time Frame: 60 days ]
    New onset organs dysfunction/failure were defined with reference to internationally accepted criteria as follows. (1) In accordance with the RIFLE criteria, acute kidney injure (AKI) defined as the sudden changes (48 hours) of renal function caused by renal structural or function damaged, showing absolute increase in serum creatinine ≥0.3 mg / dl (≥26.4umol / l), or an increase ≥50% (1.5 times the baseline value), or urine output <0.5 ml/kg/h for over 6 hours. (2) Acute liver injury is defined as ALT increased more than 1 times. (3) Acute myocardial injury is defined as emerging symptoms of myocardial ischemia. ECG changes suggested myocardial ischemia (ST segment elevation or depression, or pathologic Q waves), and biochemical markers of myocardial necrosis was typical increased (troponin and creatine kinase). (4) Based on the Berlin definition, acute lung injury is defined as oxygenation index <300mmHg with PEEP ≥5 cmH2O.

  3. the adverse events of the treatment [ Time Frame: 60 days ]
    Acute pulmonary edema, Acute myocardial infarction, Arrhythmia, Cardiac Arrest, Pneumothorax caused by the puncture, RBC allergy, Catheter-related infections


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with septic shock were assessed for inclusion, which required that patients be older than 18 years with confirmed or presumed infection, met two or more criteria for systemic inflammatory response syndrome [16], and evidence of refractory hypotension or a serum lactate level above 4 mmol per liter.
  • 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.

Exclusion Criteria:

  • 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.
More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02566460     History of Changes
Other Study ID Numbers: PUMCH-S616
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: February 2016

Keywords provided by Peking Union Medical College Hospital:
Lactate clearance
systemic central venous oxygen saturation
septic shock
haemodynamic therapy

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation