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Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329821
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Gaab Soo Kim, Samsung Medical Center

Brief Summary:
The investigators are trying to investigate metabolism of lactate sourced from IV Hartmann's solution in patients with hepatocellular carcinoma(HCC) compared with a control group(donation for liver transplantation) with normal liver function. Second purpose of this study is finding the predictive factor of changing metabolism of lactate sourced from IV Hartmann's solution in patients with HCC.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Liver Disease Other: hartmann solution

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HCC group
patients with hepatocellular carcinoma
Other: hartmann solution
hartmann solution infusion in patients for hepatic resection

donor group
patient for liver transplantation donation
Other: hartmann solution
hartmann solution infusion in patients for hepatic resection




Primary Outcome Measures :
  1. changes of lactate level [ Time Frame: at 2hour after induction ]
    hartmann solution is infused 5ml/kg/hr for 2 hour


Secondary Outcome Measures :
  1. changes of acid-base status [ Time Frame: at 2hour after induction ]
    hartmann solution is infused 5ml/kg/hr for 2 hour, changes of pH, base excess, bicarbonate level



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with hepatocelluar carcinoma
Criteria

Inclusion Criteria:

  • patients with hepatocellular carcinoma

Exclusion Criteria:

  • patients with diabetic mellitus
  • patients with electrolyte inbalance
  • patients with renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329821


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Gaab Soo Kim, M.D, Ph.D Samsung Medical Center
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Responsible Party: Gaab Soo Kim, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02329821    
Other Study ID Numbers: 2014-09-159
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015
Keywords provided by Gaab Soo Kim, Samsung Medical Center:
lactate
hartmann solution
hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases