Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

NCT07440121 | Not Yet Recruiting

• 1 other identifier: XJH-A-20260222
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Surgery

Keywords

fluid therapy; hepatectomy; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• incidence of acute kidney injury

  Postoperative acute kidney injury (AKI) was diagnosed and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury (2012). AKI was defined as the presence of any of the following criteria within 7 days after surgery: an increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; an increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume \< 0.5 mL/kg/h for 6 consecutive hours. Baseline serum creatinine was defined as the most recent preoperative value available within 3 months prior to surgery.

  from end of surgery to 7 days after surgery

Secondary Outcomes (11)

• Severity of acute kidney injury

  from end of surgery to discharge from hospital, at an average of 7 days

• number of patients with post-hepatectomy liver failure

  from end of surgery to discharge from hospital, at an average of 7 days

• number of patients with major cardiac complications

  from end of surgery to discharge from hospital, at an average of 7 days

• volume of blood loss

  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

  at the end of the surgery

Study Arms (3)

restrictive

EXPERIMENTAL

Other: restrictive fluid infusion

Restrictive plus preload

EXPERIMENTAL

Other: restrictive fluid infusion; Other: preload

restrictive plus preload plus nitro

EXPERIMENTAL

Other: restrictive fluid infusion; Other: preload; Other: nitro

Interventions

restrictive fluid infusion OTHER

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

Restrictive plus preload; restrictive; restrictive plus preload plus nitro

preload OTHER

6 ml·kg- 1·h- 1 of hydroxyethyl starch solution is infused before anesthesia

Restrictive plus preload; restrictive plus preload plus nitro

nitro OTHER

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.

restrictive plus preload plus nitro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for elective hepatectomy under general anesthesia
• age ≥18 yrs old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhihong LU: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018; deerlu23@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): February 2, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publication
• Access Criteria: with reasonable request to Dr. Zhihong Lu at deerlu23@163.com