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.
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.
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.
- Conditions
- Hepatocellular Carcinoma, Liver Disease
- 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 group | Role | What they receive |
|---|---|---|
| HCC group | patients with hepatocellular carcinoma Receives: Other: hartmann solution | |
| donor group | patient 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.
changes of lactate level
hartmann solution is infused 5ml/kg/hr for 2 hour
Measured: at 2hour after induction
Secondary outcomes (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.
- First posted1 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaab Soo Kim, Samsung Medical Center
- Investigators
- Gaab Soo Kim, M.D, Ph.D, Principal investigator, Samsung Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection
- ClinicalTrials.gov ID
- NCT02329821
- Acronym / sponsor ID
- 2014-09-159
- Conditions
- Hepatocellular Carcinoma, Liver Disease
- Keywords
- lactate, hartmann solution, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jan 2015 (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 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC group | – | Other: hartmann solutionpatients with hepatocellular carcinoma |
| donor group | – | Other: hartmann solutionpatient for liver transplantation donation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hepatocelluar carcinoma
Key inclusion criteria (1 listed)
- patients with hepatocellular carcinoma
Key exclusion criteria (3 listed)
- patients with diabetic mellitus
- patients with electrolyte inbalance
- patients with renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hartmann solutionhartmann solution infusion in patients for hepatic resection | Other | HCC group, donor group |
Primary outcome
changes of lactate level
Time frame: at 2hour after induction
hartmann solution is infused 5ml/kg/hr for 2 hour
1 secondary outcome
changes of acid-base status
Time frame: at 2hour after induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
Gaab Soo Kim, M.D, Ph.D 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 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.