Trial Outcomes & Findings for Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department (NCT NCT01947127)

Results Overview

Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.

Recruitment status

COMPLETED

Target enrollment

458 participants

Primary outcome timeframe

72 hours after venous lactate measurement

Results posted on

2016-12-02

Participant Flow

Recruitment started at April 2013 to October 2014 at King Chulalongkorn Memorial Hospital, a university-affiliated, 1,500 bed, tertiary care urban hospital

Participant milestones

Participant milestones
Measure	High Lactate Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate Initial venous lactate level less than 2.0 mmol/L
Overall Study STARTED	166	292
Overall Study COMPLETED	143	249
Overall Study NOT COMPLETED	23	43

Reasons for withdrawal

Reasons for withdrawal
Measure	High Lactate Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate Initial venous lactate level less than 2.0 mmol/L
Overall Study Protocol Violation	18	38
Overall Study Withdrawal by Subject	1	1
Overall Study Data loss	4	4

Baseline Characteristics

Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Lactate n=143 Participants Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate n=249 Participants Initial venous lactate level less than 2.0 mmol/L	Total n=392 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	143 Participants n=5 Participants	249 Participants n=7 Participants	392 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46.0 years STANDARD_DEVIATION 13.7 • n=5 Participants	42.8 years STANDARD_DEVIATION 14.4 • n=7 Participants	44.0 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	120 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	129 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Thai and Southeast Asian	143 participants n=5 Participants	249 participants n=7 Participants	392 participants n=5 Participants
Region of Enrollment Thailand	143 participants n=5 Participants	249 participants n=7 Participants	392 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours after venous lactate measurement

Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.

Outcome measures

Outcome measures
Measure	High Lactate n=143 Participants Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate n=249 Participants Initial venous lactate level less than 2.0 mmol/L
Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator	53 participants	21 participants

SECONDARY outcome

Timeframe: 30 days after the day of presentation to the emergency department

Population: Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis.

Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis.

Outcome measures

Outcome measures
Measure	High Lactate n=139 Participants Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate n=249 Participants Initial venous lactate level less than 2.0 mmol/L
All-cause Mortality Rates	18 participants	13 participants

SECONDARY outcome

Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 7 days

Numbers of days spent in the hospital since the emergency department arrival to hospital discharge

Outcome measures

Outcome measures
Measure	High Lactate n=143 Participants Initial venous lactate level equal to or more than 2.0 mmol/L	Low Lactate n=249 Participants Initial venous lactate level less than 2.0 mmol/L
Hospital Length of Stay	6 Days Interval 2.0 to 14.0	3 Days Interval 2.0 to 8.0

Adverse Events

High Lactate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Lactate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Khrongwong Musikatavorn, M.D.

Faculty of Medicine, Chulalongkorn University

Phone: +6622564553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place