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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01947127
• Collaborator: (none)
• Enrollment: 458
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

To investigate the role of initial venous lactate in predicting the severity progression to overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who suspected to have acute infections.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Disease Progression; Septic Shock; Fatal Outcome

Detailed Description

Blood lactate is one of the markers that can predict the organ failures and mortality in emergency department (ED) patients with sepsis. Regarding its predictive role in the clinical deterioration in normotensive sepsis patients, a recent prospective observational study of the patients with moderately-high serum lactate (2.0-3.9 mmol/L) showed that one-forth of the patients eventually developed progressive organ dysfunctions or required vasopressor or mechanical ventilator. Unfortunately, low serum lactate (< 2.5 mmol/L) was still found up to 50% of overt septic shock patients, even in vasopressor-dependent cases. For the prognostic role on mortality, numbers of articles showed that blood lactate can also predict death in sepsis patients, especially in those who are elderly and critically-ill. However, no previous study was done in younger patients since lactate kinetics in the body may differ among the age groups. The primary aim of our study is to investigate the role of initial venous lactate levels in predicting the chance of severity progression to overt septic shock especially in non-elderly patients who suspected to have acute infections and without hemodynamic shock in ED. The secondary outcomes are to evaluate its prognostic role on hospital length of stay and 30-day mortality of this target population.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 458 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Can Venous Lactate Predict the Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients Without Hemodynamic Shock in Emergency Department?
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator [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.

Secondary Outcome Measures

1. All-cause Mortality Rates [30 days after the day of presentation to the emergency department]

   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.

2. Hospital Length of Stay [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 to 65 years

• Confirmed or suspected diagnoses of acute infections (within 7 days)

• Major infections (e.g. Acute pyelonephritis, Acute bronchitis/pneumonia, Acute hepatobiliary tract infections, intrabdominal abscesses, meningitis and other central nervous system infections, soft tissue infections involving more than 10 square centimeters of the skin surface or deeper down beyond the dermis, significant tropical infections; dengue fever, leptospirosis, typhus fevers, or high fever from any infectious sources)

• Systolic blood pressure more than 90 mmHg at presentation

• Mean arterial pressure more than 70 mmHg at presentation

Exclusion Criteria:

• Duplicated cases that have participated in this study during the study period

• Overt organ hypoperfusion (e.g. cold, clammy or mottling skin, altered mental status; Glasgow Coma Scale equal to or less than 12 or decrease > 1 compared with the baseline)

• Pulse oximetry equal to or less than 90% at ambient air

• received intravenous fluid more than 10 ml/kg prior to the venous blood sampling

• received intravenous antibiotics for more than 1 hours prior to the venous blood sampling

• Minor infections (e.g. uncomplicated upper respiratory tract infections, gastroenteritis, minor skin infections)

• currently taking antiretroviral drugs

• having or suspicious of having seizures in the past 72 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emergency Medicine Unit, King Chulalongkorn Memorial Hospital	Patumwan	Bangkok	Thailand	11130

Sponsors and Collaborators

• Chulalongkorn University

Investigators

• Principal Investigator: Khrongwong Musikatavorn, MD, Department of Medicine, Facalty of medicine, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khrongwong Musikatavorn, MD., Khrongwong Musikatavorn, MD, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT01947127
• Other Study ID Numbers: 793/2012
• First Posted: Sep 20, 2013
• Last Update Posted: Dec 2, 2016
• Last Verified: Apr 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Khrongwong Musikatavorn, MD., Khrongwong Musikatavorn, MD, Chulalongkorn University: Lactate; Sepsis; Septic shock; Disease progression; Prognosis
• Additional relevant MeSH terms: Sepsis; Toxemia; Shock, Septic; Emergencies; Shock; Disease Progression

Study Results

Participant Flow

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

Arm/Group Title	High Lactate	Low Lactate
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L	Initial venous lactate level less than 2.0 mmol/L
Period Title: Overall Study
STARTED	166	292
COMPLETED	143	249
NOT COMPLETED	23	43

Baseline Characteristics

Arm/Group Title	High Lactate	Low Lactate	Total
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L	Initial venous lactate level less than 2.0 mmol/L	Total of all reporting groups
Overall Participants	143	249	392
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	143 100%	249 100%	392 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.0 (13.7)	42.8 (14.4)	44.0 (14.2)
Sex: Female, Male (Count of Participants)
Female	64 44.8%	120 48.2%	184 46.9%
Male	79 55.2%	129 51.8%	208 53.1%
Race/Ethnicity, Customized (participants) [Number]
Thai and Southeast Asian	143 100%	249 100%	392 100%
Region of Enrollment (participants) [Number]
Thailand	143 100%	249 100%	392 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator
Description	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.
Time Frame	72 hours after venous lactate measurement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Lactate	Low Lactate
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L	Initial venous lactate level less than 2.0 mmol/L
Measure Participants	143	249
Number [participants]	53 37.1%	21 8.4%

2. Secondary Outcome

Title	All-cause Mortality Rates
Description	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.
Time Frame	30 days after the day of presentation to the emergency department

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	High Lactate	Low Lactate
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L	Initial venous lactate level less than 2.0 mmol/L
Measure Participants	139	249
Number [participants]	18 12.6%	13 5.2%

3. Secondary Outcome

Title	Hospital Length of Stay
Description	Numbers of days spent in the hospital since the emergency department arrival to hospital discharge
Time Frame	Patients will be followed for the duration of hospital stay, an expected average of 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Lactate	Low Lactate
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L	Initial venous lactate level less than 2.0 mmol/L
Measure Participants	143	249
Median (Inter-Quartile Range) [Days]	6	3

Adverse Events

Time Frame	Overall study period
Arm/Group Title	High Lactate		Low Lactate
Arm/Group Description	Initial venous lactate level equal to or more than 2.0 mmol/L		Initial venous lactate level less than 2.0 mmol/L
All Cause Mortality
	High Lactate		Low Lactate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	High Lactate		Low Lactate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/143 (0%)		0/249 (0%)
Other (Not Including Serious) Adverse Events
	High Lactate		Low Lactate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/143 (0%)		0/249 (0%)

Limitations/Caveats

1. This was an observational study that did not evaluate the aggressiveness of the treatment strategies. 2. The study was done in a single, urban, university hospital. 3. The staging of co-morbidity (e.g. cancers) was not well-categorized.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.