Back to resultsThe Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resuscitation
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Lactate clearance, systemic central venous oxygen saturation, septic shock, haemodynamic therapy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
lactate clearance group
SCVO2 group
Arm Description
Refer to lactate clearance rate to perform resuscitation therapy
Refer to SCVO2 to perform resuscitation therapy
Outcomes
Primary Outcome Measures
60-day mortality
Secondary Outcome Measures
ventilator-free days
organs dysfunction/failure
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.
the adverse events of the treatment
Acute pulmonary edema, Acute myocardial infarction, Arrhythmia, Cardiac Arrest, Pneumothorax caused by the puncture, RBC allergy, Catheter-related infections
Full Information
NCT ID
NCT02566460
First Posted
September 26, 2015
Last Updated
April 30, 2016
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02566460
Brief Title
The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Lactate clearance, systemic central venous oxygen saturation, septic shock, haemodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lactate clearance group
Arm Type
Experimental
Arm Description
Refer to lactate clearance rate to perform resuscitation therapy
Arm Title
SCVO2 group
Arm Type
Sham Comparator
Arm Description
Refer to SCVO2 to perform resuscitation therapy
Intervention Type
Other
Intervention Name(s)
Resuscitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
60-day mortality
Time Frame
60 days
Secondary Outcome Measure Information:
Title
ventilator-free days
Time Frame
60 days
Title
organs dysfunction/failure
Description
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.
Time Frame
60 days
Title
the adverse events of the treatment
Description
Acute pulmonary edema, Acute myocardial infarction, Arrhythmia, Cardiac Arrest, Pneumothorax caused by the puncture, RBC allergy, Catheter-related infections
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
28202033
Citation
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.
Results Reference
derived
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The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock
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