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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactate clearance group | Experimental | Refer to lactate clearance rate to perform resuscitation therapy |
|
| SCVO2 group | Sham Comparator | Refer to SCVO2 to perform resuscitation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 60-day mortality | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| ventilator-free days | 60 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28202033 | Derived | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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|
| 60 days |
| 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 | 60 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |