Preoperative Sildenafil Administration for Hepatectomy

June 25, 2024 updated by: zhiming zhang, First People's Hospital of Chenzhou
Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. It mainly consists of fluid restriction, position adjustment, and the use of vasodilators. However, these measures focus on decreasing CVP by reducing the volume of return blood, and less attention is paid to factors such as pulmonary vascular resistance and cardiac function. Sildenafil, known as Viagra, is currently used to treat erectile dysfunction and pulmonary hypertension in men. Its action inhibits phosphodiesterase-5 (PDE-5) and increases cGMP levels, leading to smooth muscle relaxation and vasodilation. Its pharmacological properties provide potential value for the treatment of many diseases. However, few studies have been conducted both domestically and internationally on the use of sildenafil citrate in liver resection related to CLCVP. This study aims to investigate the influence of preoperative oral administration of Sildenafil Citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy and to provide empirical support for the potential value of Sildenafil Citrate or Sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Feasibility/Effectiveness evaluation indicators:

    Primary outcomes：

    • Intraoperative blood loss: To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
    • The classification of the surgical field: At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process.

    Secondary outcomes:

    • Cumulative consumption of nitroglycerine: Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
    • Hemodynamic parameters: Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.

  2. Safety evaluation indicators:

    • Blood gas analysis: Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.
    • Coagulation function：Understand the changes in the coagulation function of the patient during the operation by measuring the TEG of the patient at T2 and T5, and measure the APTT and PT values at D1, D3, and D5 to understand whether there is an impact on the patient's postoperative coagulation function after taking Sildenafil.
    • Intraoperative urine output: By recording the intraoperative urine output value of the patient at T6.
    • Adverse events in the recovery room：It is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room.
    • Biochemical markers (Liver and kidney functions): It is evaluated by measuring the levels of TBil, Alb, AST, ALT, Cr, BUN of the patients on days -D1, D1, D3, and D5.
    • Complete blood count: At -D1, D1, D3, and D5, it is evaluated by measuring the patient's postoperative Hb, Plt, and Hct.
    • Cardiac function: By comparing the levels of BNP, CK-MB, and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patient's cardiac function.
    • Postoperative hospital stay and drainage indwelling time: Record the patient's hospital stay and drainage tube placement time to assess the patient's recovery speed.

    • Postoperative complications: Whether to enter the ICU after surgery, liver failure, bleeding, bile leakage, ascites, pleural effusion, and incision site infection.

      • (- D1: The day before surgery; - T0: half an hour before surgery; T0: entering the operating room; T1: post induction; T2: 5 minutes after 30° head-up and foot-down position; T3: 30 minutes after the start of liver resection; T4: 60 minutes after the start of liver resection; T5: after liver resection; T6: at the end of the operation; D1: Postoperative day 1; D3: Postoperative day 3; D5: Postoperative day 5)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Chenzhou, Hunan, China, 423000
        • Recruiting
        • Zhiming Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing hepatic resection
  • age from 18-85 years
  • Child-Pugh ≤B
  • ASA II-III
  • willing to join the trial.

Exclusion Criteria:

  • Pregnancy or Lactation
  • Known Allergy to any Medications used in the Study
  • Hemoglobin (Hb) < 90 g/L
  • Body Mass Index (BMI) > 35 kg/m2 or < 18 kg/m2
  • Hypertension > 180 mmHg
  • Renal Impairment (Creatinine, Cr 178 µmol/L)
  • Severe Cardiovascular Diseases including Active Coronary Artery Disease, Severe Valve Stenosis and Hypertrophic Obstructive Cardiomyopathy, History of Stroke Within Six Months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: calcium tablet
Drug: Sildenafil 100 MG
Sildenafil 100mg orally half an hour before surgery
Other Names:
  • nitroglycerine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: At the end of the operation
To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
At the end of the operation
The classification of the surgical field
Time Frame: At the end of the operation
At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process.(At 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
At the end of the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative consumption of nitroglycerine
Time Frame: At the end of the operation
Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
At the end of the operation
Hemodynamic parameters
Time Frame: At the end of the operation
Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.
At the end of the operation
Blood gas analysis
Time Frame: At the end of the operation
Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.(At post induction(T1), 5 minutes after 30° head-up and foot-down position(T2), 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
At the end of the operation
Intraoperative urine output
Time Frame: At the end of the operation(T6)
By recording the intraoperative urine output value of the patient at T6.
At the end of the operation(T6)
Adverse events in the recovery room
Time Frame: After the end of surgery, Patient in recovery room.
It is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room.
After the end of surgery, Patient in recovery room.
Liver function
Time Frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
It is evaluated by measuring the levels of TBil, Alb, AST, ALT of the patients on days -D1, D1, D3, and D5.
At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
kidney function
Time Frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
It is evaluated by measuring the levels of Cr, BUN of the patients on days -D1, D1, D3, and D5.
At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Complete blood count
Time Frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
At -D1, D1, D3, and D5, it is evaluated by measuring the patient's postoperative Hb, Plt, and Hct.
At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Cardiac function
Time Frame: At Postoperative day 1
By comparing the levels of BNP, CK-MB, and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patient's cardiac function.
At Postoperative day 1
Postoperative hospital stay
Time Frame: At Postoperative day 5
Record the patient's hospital stay to assess the patient's recovery speed.
At Postoperative day 5
Drainage indwelling time
Time Frame: At Postoperative day 5
Record the drainage tube placement time to assess the patient's recovery speed.
At Postoperative day 5
Postoperative complications
Time Frame: At postoperative day 1, postoperative day 3 and postoperative day 5
Whether to enter the ICU after surgery, liver failure, bleeding, bile leakage, ascites, pleural effusion, and incision site infection.
At postoperative day 1, postoperative day 3 and postoperative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First People's Hospital of Chenzhou

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhi-ming Z Zhang, Chenzhou NO. 1 people's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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