Shock, Septic Clinical Trial
Official title:
Strategy of Early Improvement of Tissue Oxygenation Decrease the Mortality of Severe Sepsis
The impact of lactate guided therapy on septic shock has not been extensively investigated,
however the goal directed therapy has been used for years. The investigators aim was to test
the hypothesis that lactate directed hemodynamic therapy is associated with improving the
outcome of patients with septic shock by comparing different goal directed strategies which
have been commonly recommended clinically.
In this multicenter, randomized trial, the investigators assigned patients with septic shock
to three groups: Patients were treated with hemodynamic therapy directed either by
conventional parameters treatment (control group), or central venous oxygen saturation
(ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of
death at 28 days after randomization and in-hospital mortality; secondary end points include
hemodynamic states, time to goal-achievement.
This prospective, randomized, controlled and multi-center study was performed in 6 closed
intensive care units (ICU) of academic tertiary hospitals. Adult patients with septic shock
admitted to the hospitals from 2005 to 2008 were assigned to the study eligibility. Eligible
patients were centrally randomized using sealed envelopes into one of the three groups which
included lactate, ScvO2, and control groups. The criteria of septic shock included two of
four criteria for the systemic inflammatory response syndrome and systolic blood pressure
lower than 90 mmHg or decrease of systolic blood pressure more than 40 mmHg after fluid
challenge and the clinical signs of tissue hypoperfusion, including oliguria, blood lactate
concentration of 4 mmol/L or more and consciousness alteration. 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 intraabdominal infective focus without drainage, severe bronchopleural
fistula, seizure, during chemotherapy or immunosuppressive therapy, or end stage of the
diseases.
The protocol was approved by Institutional Ethics Committee. The informed consents were
obtained from all patients or their legally authorized next of kin. The patients or their
legal surrogate decision makers were informed of their right to refuse the study procedures
at any time during the protocols were performed.
The case report forms (CRF) were sent to each site from the principal investigator with the
protocols, which were randomly sealed in a serial of envelopes. After patients' enrollment,
the CRFs were filled by the attending physicians at each site according to the protocol of
each group. End points were 28-day mortality and in-hospital mortality until 90 days. The
demographic data, acute physiological and chronic evaluation score (APACHE) II and other data
from patients' basic condition were recorded at enrollment day. The protocol related data
were collected at baseline and each hour for 6 hours and then at 12, 24, 36, 48, 60, 72
hours. The ICU and hospital length of stay were also noted and patients were followed up to
day 28 and discharge from hospital for mortality. The protocol implementation and data
collection stopped when patients or their families wished to withdraw from the program or
refuse further treatment or a patient's death.
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