Not yet recruiting NCT07440121
Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: restrictive fluid infusion, preload, nitro.
- Who it may be relevant to
- Registry conditions: Anesthesia, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Different Fluid Therapy on Major Postoperative Morbidity in Patients Undergoing Non-donor Hepatectomy: a Pilot Trial
Overview
During hepatectomy, surgeons often prefer to restrict fluid intake, believing that this can lower central venous pressure (CVP) and reduce intraoperative blood loss. However, fluid restriction may lead to inadequate perfusion of vital organs and even contribute to postoperative organ dysfunction, such as acute kidney injury (AKI). Therefore, this study aims to compare the effects of restrictive versus liberal fluid therapy on major complications following hepatectomy.
Interventions
- Other restrictive fluid infusion
Fluid infusion is restricted at 2 ml·kg- 1·h- 1 from the moment the patient arrive in the operating room to immediately after the liver lesions are removed - Other preload
6 ml·kg- 1·h- 1 of hydroxyethyl starch solution is infused before anesthesia - Other nitro
Nitroglycerin is infused from start of anesthesia to immediately after the liver lesions are removed.The starting infusion rates of nitroglycerin is 0.5 μg·kg- 1·min- 1 . If the speed of administration requires adjustment, nitroglycerin is added or decreased by 0.1 μg·kg- 1·min- 1.
Primary outcome measures
- incidence of acute kidney injury [Time frame: from end of surgery to 7 days after surgery]
Secondary outcome measures (11)
- Severity of acute kidney injury [Time frame: from end of surgery to discharge from hospital, at an average of 7 days]
- number of patients with post-hepatectomy liver failure [Time frame: from end of surgery to discharge from hospital, at an average of 7 days]
- number of patients with major cardiac complications [Time frame: from end of surgery to discharge from hospital, at an average of 7 days]
- volume of blood loss [Time frame: from start of surgery to end of surgery, at an average of 3 hours]
- numerical rating scale of surgeon's satisfaction to the surgical field [Time frame: at the end of the surgery]
- control of central venous pressure during resection [Time frame: from start of resection to end of removal of the liver lesions ,at an average of 2 hours]
- dose of norepinephrine [Time frame: from start of surgery to end of surgery, at an average of 3 hours]
- frequency of hypotension [Time frame: from start of surgery to end of surgery, at an average of 3 hours]
- arterial lactate level [Time frame: upon completion of surgery，that is, end of incision suture，at an average of 3 hours after anesthesia induction]
- arterial lactate level [Time frame: When the liver lesions are removed，at an average of 2 hours after anesthesia induction]
- surgical field bleeding score [Time frame: at the end of the surgery, ，at an average of 3 hours after anesthesia induction]
Eligibility criteria
Inclusion criteria
- scheduled for elective hepatectomy under general anesthesia
- age ≥18 yrs old
Exclusion criteria
- American society of anesthesiologists status over 3
- existed kidney disease or renal dysfunction
- severe cardiac or respiratory dysfunction
- neurological or psychiatric disease
- Child-Pugh class C (score 10-15)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Wang F, Sun D, Zhang N, Chen Z. The efficacy and safety of controlled low central venous pressure for liver resection: a systematic review and meta-analysis. Gland Surg. 2020 Apr;9(2):311-320. doi: 10.21037/gs.2020.03.07. PMID 32420255
- Li S, Yin Y, Wang P, Jiang L, Yan H, Cang J. Goal-directed fluid therapy during post-resection phase in low central venous pressure assisted laparoscopic hepatectomy: a randomized controlled superiority trial. J Anesth. 2024 Feb;38(1):77-85. doi: 10.1007/s00540-023-03282-5. Epub 2023 Dec 13. PMID 38091035
- Phothikun N, Pantatong O, Kulpanun M, Wongpunkamol S, Lapisatepun W, Phothikun A, Lapisatepun W. The impact of perioperative positive fluid balance on postoperative acute kidney injury in patients undergoing open hepatectomy: A retrospective single center cohort study. PLoS One. 2025 Apr 1;20(4):e0319856. doi: 10.1371/journal.pone.0319856. eCollection 2025. PMID 40168322
Identifiers
NCT: NCT07440121 · XJH-A-20260222