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Hepatic IschemiaNCT05830136

Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

A study testing sodium bicarbonate Ringer's solution in people with Hepatic Ischemia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatic Ischemia
What is being tested?
sodium bicarbonate Ringer's solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Feb 2022to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years old,
  • patients who plan to undergoing laparoscopic hepatectomy ;
  • Willing to sign informed consent.

Who cannot join

  • age <18 years
  • pregnancy
  • active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
  • history of significant cerebrovascular disease
  • restrictive or obstructive pulmonary disease
  • uncontrolled hypertension
Show all 9Show fewer
  • renal dysfunction (glomerular filtration rate <60 mL/min),
  • evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
  • presence of active infection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shijiang Liu contact

02568303569

liushijiang@jsph.org.cn

China1 site, 1 recruiting

  • Shijiang Liu

    Nanjing, Jiangsu, 210029

    Shijiang Liu, MD, +86-25-68303569, liushijiang@jsph.org.cn

    Shijiang Liu, MD, liushijiang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy

Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy.

Read the detailed description

The study was a single-center prospective randomized controlled study. A total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: Group A, sodium bicarbonate Ringer's solution group(n=50); Group B, Lactate Ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); Collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (T0), during liver specimens resected(T1), after liver specimens resected(T2), and the end of surgery (T3). Then statistical analysis and observe the application prospect of sodium bicarbonate Ringer's injection in Laparoscopic hepatectomy.

Being tested
sodium bicarbonate Ringer's solution

What participants receive

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

  • sodium bicarbonate Ringer's solutionDrug

    Also called lactated Ringer's solution

    Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.

Study groups in NCT05830136
Study groupRoleWhat they receive
Group AExperimentalSodium bicarbonate Ringer's solution group
Receives: Drug: sodium bicarbonate Ringer's solution
Group BActive comparatorLactate Ringer's solution group
Receives: Drug: sodium bicarbonate Ringer's solution

What is being measured

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

  1. lactic values

    to compare the conditions of acid-base balance and internal environment between the two groups

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

Secondary outcomes (28)

  1. Amount of sodium bicarbonate injection (ml)

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

  2. Value of pH

    Measured: From the start of operation until the end of operation (during the operation).

  3. Concentration of HCO3-

    Measured: From the start of operation until the end of operation (during the operation).

  4. Value of BE

    Measured: From the start of operation until the end of operation (during the operation).

  5. Concentration of Glucose

    Measured: From the start of operation until the end of operation (during the operation).

  6. Value of MAP

    Measured: From the start of operation until the end of operation (during the operation).

  7. Value of HR

    Measured: From the start of operation until the end of operation (during the operation).

  8. Concentration of CI

    Measured: From the start of operation until the end of operation (during the operation).

  9. Value of SVV

    Measured: From the start of operation until the end of operation (during the operation).

  10. Value of SVR

    Measured: From the start of operation until the end of operation (during the operation).

  11. Value of PPV

    Measured: From the start of operation until the end of operation (during the operation).

  12. Amount of norepinephrine

    Measured: From the start of operation until the end of operation (during the operation).

  13. Amount of phenylephrine

    Measured: From the start of operation until the end of operation (during the operation).

  14. Amount of ephedrine

    Measured: From the start of operation until the end of operation (during the operation).

  15. Amount of nitroglycerin

    Measured: From the start of operation until the end of operation (during the operation).

  16. Amount of milrinone

    Measured: From the start of operation until the end of operation (during the operation).

  17. Amount of furosemide

    Measured: From the start of operation until the end of operation (during the operation).

  18. time of palinesthesia from general anesthsia

    postoperative palinesthesia, recovering time

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

  19. time of stay in PACU

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

  20. extubation time

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

  21. Concentration of BUN

    Measured: day 1 and day 3 after surgery.

  22. Concentration of Cr

    Measured: day 1 and day 3 after surgery.

  23. Value of AST

    Measured: day 1 and day 3 after surgery.

  24. Value of ALT

    Measured: day 1 and day 3 after surgery.

  25. Amount of blood loss

    amount of blood loss during the operation.

    Measured: intraoperative

  26. Amount of blood transfusion

    amount of blood transfusion during the operation.

    Measured: intraoperative

  27. urinary output

    amount of urinary output during the operation.

    Measured: intraoperative

  28. 15-item quality of recovery scale scores (QoR-15)

    15-item quality of recovery scale scores. the minimum value is 0 and maximum value is 150, and whether higher scores mean a better outcome.

    Measured: day 1 and day 3 after surgery.

Timeline

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

  1. First posted26 Apr 2023
  2. Study start1 Feb 2022
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830136
Sponsor's protocol ID
2021-SR-386
Status last verified
Nov 2024
First submitted
27 Feb 2023
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing sodium bicarbonate Ringer's solution in people with Hepatic Ischemia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Shijiang Liu (02568303569, liushijiang@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lactic values (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.). 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 NCT05830136.

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 12 Nov 2024.

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