Clinical trial NCT05887661: Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy
Official title: The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hypovolemic phlebotomy
low central venous pressure
goal-directed
laparoscopic hepatectomy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are:

1. The safety and feasibility of HP
2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Hepatocellular Carcinoma
* Preference for laparoscopic hepatectomy and patient agreement

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Refusal of blood product transfusion
* 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
* Renal dysfunction (glomerular filtration rate \<60 mL/min),
* Hemoglobin \<100 g/L
* Abnormal coagulation values (international normalized ratio \>1.5 not on warfarin and/or platelet count \<100 ×109/L)
* Evidence of hepatic metabolic disorder (bilirubin \>35 mmol/L)
* Presence of active infection
* Preoperative autologous blood donation
* Patients were not allowed to receive erythropoietin at any time during the index hospitalization.

Primary outcomes:
measure: The proportion of allogeneic red blood cell products transfusion
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes:
measure: The volume of Phlebotomy
timeFrame: From the start of operation until the end of operation.
measure: The volume of Intraoperative blood loss
timeFrame: From the start of operation until the end of operation (during the operation).
measure: The volume of Allogeneic transfusion (perioperative)
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
measure: The volume of Allogeneic transfusion (postoperative)
timeFrame: From the end of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
measure: The volume of Allogeneic transfusion (intraoperative)
timeFrame: From the start of operation until the end of operation.
measure: The volume of Fresh frozen plasm (FFP) transfusion
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
measure: The volume of Platelets transfusion
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
measure: The volume of Albumin transfusion
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
measure: Perioperative lowest concentration of Hb
timeFrame: From the start of operation until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months.
measure: Pre-transection central venous pressure (CVP), (basic CVP)
timeFrame: From the start of anesthesia induction until the star of operation.
measure: Lowest central venous pressure (CVP)
timeFrame: From the start of operation until the end of operation (during the operation).
measure: time of pringle maneuver
timeFrame: From the start of operation until the end of operation.
measure: number of pringle maneuver
timeFrame: From the start of operation until the end of operation.
measure: operating time
timeFrame: From the start of operation until the end of operation.
measure: The proportion of laparoscopic hepatectomy converted to open liver resection
timeFrame: From the start of operation until the end of operation.
measure: Length of stay
timeFrame: From date of hospitalization until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months
measure: Number of Participants with postoperative complications (overall)
timeFrame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 months.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shijiang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: