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Hepatocellular CarcinomaNCT02329821

Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection

An observational study of Hepatocellular Carcinoma and Liver Disease, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Hepatocellular Carcinoma, Liver Disease
What is being tested?
hartmann solution
Type of treatment
Injection or infusion
How many people
72 participants
Where
1 siteSouth Korea
Study dates
Nov 2014to Jun 2015
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with hepatocelluar carcinoma

Who may be able to join

  • patients with hepatocellular carcinoma

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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.

Read the detailed description

The liver is important in acid-base physiology and electrolyte balance. It is important because it is a metabolically active organ which may be either a significant net producer or consumer of hydrogen ions.

Lactate is produced in the peripheral tissues such as the muscles, skin, brain, and red blood cells and it is metabolized predominantly in the liver and kidneys, first to pyruvate and secondly to glucose. In the healthy liver, there is a net-uptake of lactate caused by gluconeogenesis, and the liver exhibits a higher net lactate clearance than any other organ anticipated to be up to 70% of the whole body clearance. Lactic acidosis will result if this hepatic metabolism is not adequate.

Hartmann's solution, which contains 28 mmol/l of lactate and has a pH of 6.5, has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. Excessive use of saline has been observed to result in hyperchloraemic acidosis - which has been identified as a potential side effect of saline based solutions. It has been suggested that the use of balanced electrolyte solutions may avoid this effect.

A previous study concerned that normal saline, which does not contain lactate, might be detrimental to liver donors because of an association with hyperchloremic metabolic acidosis.

Metabolism of lactate sourced from IV Hartmann's solution also results in a net consumption of H+, but as this lactate was associated with Na+, the overall result is a net bicarbonate production. Effectively, metabolism of this lactate results in generation of an equivalent amount of bicarbonate. The investigators are evaluating about the metabolism of lactate sourced from IV Hartmann's solution in patients with HCC and donor for liver transplantation (control group).

All patients underwent multiple medical assessments before surgery, including routine laboratory tests (complete blood counts, standard liver and renal function tests, coagulation tests, and viral serology), and electrocardiography, chest X-ray, hepatobiliary imaging, percutaneous liver biopsy, and indocyanine green retention testing (ICG test). Hartmann solution(Hartmann, Choongwae pharmaceutical, Seoul, Korea) solution is composed of 130 mmol/l sodium,109 mmol/l chloride, 4 mmol/l potassium,1.5 mmol/l calcium, and 28 mmol/l lactate, and has a pH of 6.5.

Briefly, anesthesia was induced with thiopental sodium (5 mg/kg), and vecuronium(0.15 mg/kg). Endotracheal intubation was performed, and general anesthesia was maintained with sevoflurane (2-3 vol% in 50% air and oxygen). Throughout the surgery, the patients are monitored electrocardiography, pulse oximetry, capnography, esophageal temperature, invasive arterial pressure (via a radial artery catheter). Fluid administration(Hartmann solution) begin upon arrival in the operating room with 5ml/kg/hour rate. Acid-base status and lactate, electrolyte, and hemoglobin concentrations were assessed immediately and 2 hour after induction of anesthesia. The infusion rate of fluid is 5ml/kg/hour. The reasons of that rate are intravenous crystalloid administration has been restricted during hepatic dissection at the request of the surgeon and the investigators considered about the requirement of fluid loss. Mean arterial blood pressure >60mmHg and urine output >0.5 ml/kg/h were maintained during anesthesia. When mean arterial blood pressure was < 60 mmHg, the volume of fluid administered was increased initially and/or intravenous ephedrine (5-10 mg) was injected, as appropriate. If it cannot maintain the hemodynamic stability and need more fluid administration, the investigators manage other fluid administration or inotropics, and the case is withdrawn.

Duration of 2 hours, volumes of Hartmann solution and the result of arterial blood gas analysis (Acid-base status and lactate, electrolyte, and hemoglobin concentrations were assessed immediately and 2 hour after induction of anesthesia) is recorded.

The investigators compare the change of lactate level of patients with HCC and a control group( donation for liver transplantation) with normal liver function. After evaluating metabolism of exogenous lactate, the investigators are trying to find the predictive factor (among liver profile lab, MELD score, INR, functional liver volume, ICG test) of changing metabolism of lactate sourced from IV Hartmann's solution in patients with HCC.

Being tested
hartmann solution
Keywords
lactate, hartmann solution, hepatocellular carcinoma
Medical subject headings
Carcinoma, Hepatocellular, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hartmann solutionOther

    hartmann solution infusion in patients for hepatic resection

Study groups in NCT02329821
Study groupRoleWhat they receive
HCC grouppatients with hepatocellular carcinoma
Receives: Other: hartmann solution
donor grouppatient for liver transplantation donation
Receives: Other: hartmann solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes of lactate level

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

    Measured: at 2hour after induction

Secondary outcomes (1)
  1. changes of acid-base status

    hartmann solution is infused 5ml/kg/hr for 2 hour, changes of pH, base excess, bicarbonate level

    Measured: at 2hour after induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

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
Case-control
Time perspective
Prospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02329821
Sponsor's protocol ID
2014-09-159
Status last verified
Jul 2015
First submitted
23 Dec 2014
Last updated
13 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Liver Disease, 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: finished, as of the sponsor's last update on 13 Jul 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes of lactate level (time frame: at 2hour after induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Jul 2015.

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