SepsisNCT01709565
Lactate Clearance According to the Presence of Hepatic Dysfunction
An observational study of Sepsis and Liver Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis, Liver Failure
- How many people
- 245 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department and meeting criteria for severe sepsis or septic shock at Samsung Medical Center (a 1,960 bed, university-affiliated, tertiary referral hospital in Seoul, South Korea)
Who may be able to join
- Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival
Who cannot join
- Terminal malignancy or illness with a expected survival < 4 months
- Patients who previously signed "Do Not Resuscitate" or "Do Not Intubate" orders
- Patients who do not undergo the early goal-directed therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Official title: Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction
The purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction.
Read the detailed description
Lactate clearance is well known to be associated with mortality in patients with severe sepsis and septic shock. To normalize lactate levels is one of important goals of early resuscitation of sepsis patients.
Lactate clearance can be changed by various factors including patient characteristics, severity of shock, and treatment. In particular, hepatic dysfunction might impair the clearance of lactate because liver is a principal organ for lactate metabolism. However, an association between lactate clearance and hepatic failure has not been evaluated during initial resuscitation of patients with severe sepsis and septic shock. The primary goal of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. The secondary goal is to evaluate if lactate clearance is associated with mortality even in patients with hepatic dysfunction.
- Conditions
- Sepsis, Liver Failure
- Keywords
- Sepsis, Lactic acid, Shock, Resuscitation
- Medical subject headings
- Sepsis, Liver Failure, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No hepatic dysfunction | No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl | |
| Hepatic dysfunction | Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate clearance
[(initial lactate - delayed lactate)/ initial lactate] *100%
Measured: at 6-hour from the time of enrollment
Secondary outcomes (1)
In-hospital mortality
Measured: within the first 28-day after emergency department arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo, Ik Joon, Samsung Medical Center
- Investigators
- Ik Joon Jo, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709565
- Sponsor's protocol ID
- SamsungMC
- Status last verified
- Oct 2012
- First submitted
- 17 Sep 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.
PubMed 15286537Levraut J, Ciebiera JP, Chave S, Rabary O, Jambou P, Carles M, Grimaud D. Mild hyperlactatemia in stable septic patients is due to impaired lactate clearance rather than overproduction. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1021-6. doi: 10.1164/ajrccm.157.4.9705037.
PubMed 9563714De Jonghe B, Cheval C, Misset B, Timsit JF, Garrouste M, Montuclard L, Carlet J. Relationship between blood lactate and early hepatic dysfunction in acute circulatory failure. J Crit Care. 1999 Mar;14(1):7-11. doi: 10.1016/s0883-9441(99)90002-3.
PubMed 10102718Revelly JP, Tappy L, Martinez A, Bollmann M, Cayeux MC, Berger MM, Chiolero RL. Lactate and glucose metabolism in severe sepsis and cardiogenic shock. Crit Care Med. 2005 Oct;33(10):2235-40. doi: 10.1097/01.ccm.0000181525.99295.8f.
PubMed 16215376Kang YR, Um SW, Koh WJ, Suh GY, Chung MP, Kim H, Kwon OJ, Jeon K. Initial lactate level and mortality in septic shock patients with hepatic dysfunction. Anaesth Intensive Care. 2011 Sep;39(5):862-7. doi: 10.1177/0310057X1103900510.
PubMed 21970130Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PubMed 20179283
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction
- ClinicalTrials.gov ID
- NCT01709565
- Acronym / sponsor ID
- SamsungMC
- Conditions
- Sepsis, Liver Failure
- Keywords
- Sepsis, Lactic acid, Shock, Resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction.
Detailed description
Lactate clearance is well known to be associated with mortality in patients with severe sepsis and septic shock. To normalize lactate levels is one of important goals of early resuscitation of sepsis patients.
Lactate clearance can be changed by various factors including patient characteristics, severity of shock, and treatment. In particular, hepatic dysfunction might impair the clearance of lactate because liver is a principal organ for lactate metabolism. However, an association between lactate clearance and hepatic failure has not been evaluated during initial resuscitation of patients with severe sepsis and septic shock. The primary goal of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. The secondary goal is to evaluate if lactate clearance is associated with mortality even in patients with hepatic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No hepatic dysfunction | – | –No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl |
| Hepatic dysfunction | – | –Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department and meeting criteria for severe sepsis or septic shock at Samsung Medical Center (a 1,960 bed, university-affiliated, tertiary referral hospital in Seoul, South Korea)
Key inclusion criteria (1 listed)
- Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival
Key exclusion criteria (3 listed)
- Terminal malignancy or illness with a expected survival < 4 months
- Patients who previously signed "Do Not Resuscitate" or "Do Not Intubate" orders
- Patients who do not undergo the early goal-directed therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactate clearance
Time frame: at 6-hour from the time of enrollment
[(initial lactate - delayed lactate)/ initial lactate] *100%
1 secondary outcome
In-hospital mortality
Time frame: within the first 28-day after emergency department arrival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
- Background: PubMed 15286537Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.
- Background: PubMed 9563714Levraut J, Ciebiera JP, Chave S, Rabary O, Jambou P, Carles M, Grimaud D. Mild hyperlactatemia in stable septic patients is due to impaired lactate clearance rather than overproduction. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1021-6. doi: 10.1164/ajrccm.157.4.9705037.
- Background: PubMed 10102718De Jonghe B, Cheval C, Misset B, Timsit JF, Garrouste M, Montuclard L, Carlet J. Relationship between blood lactate and early hepatic dysfunction in acute circulatory failure. J Crit Care. 1999 Mar;14(1):7-11. doi: 10.1016/s0883-9441(99)90002-3.
- Background: PubMed 16215376Revelly JP, Tappy L, Martinez A, Bollmann M, Cayeux MC, Berger MM, Chiolero RL. Lactate and glucose metabolism in severe sepsis and cardiogenic shock. Crit Care Med. 2005 Oct;33(10):2235-40. doi: 10.1097/01.ccm.0000181525.99295.8f.
- Background: PubMed 21970130Kang YR, Um SW, Koh WJ, Suh GY, Chung MP, Kim H, Kwon OJ, Jeon K. Initial lactate level and mortality in septic shock patients with hepatic dysfunction. Anaesth Intensive Care. 2011 Sep;39(5):862-7. doi: 10.1177/0310057X1103900510.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Background: PubMed 20179283Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ik Joon Jo, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Liver Failure, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ik Joon Jo, PhD (+82-2-3410-2053, drjij@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate clearance (time frame: at 6-hour from the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709565, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.