NCT02329821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

December 23, 2014

Last Update Submit

July 9, 2015

Conditions

Hepatocellular CarcinomaLiver Disease

Keywords

lactatehartmann solutionhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • changes of lactate level

    hartmann solution is infused 5ml/kg/hr for 2 hour

    at 2hour after induction

Secondary Outcomes (1)

  • changes of acid-base status

    at 2hour after induction

Study Arms (2)

HCC group

patients with hepatocellular carcinoma

Other: hartmann solution

donor group

patient for liver transplantation donation

Other: hartmann solution

Interventions

hartmann solutionOTHER

hartmann solution infusion in patients for hepatic resection

HCC groupdonor group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hepatocelluar carcinoma

You may qualify if:

  • patients with hepatocellular carcinoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Diseases

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System Diseases

Study Officials

  • Gaab Soo Kim, M.D, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 23, 2014

First Posted

January 1, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

KR(1)