Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection (SHIELD-pilot)

February 25, 2026 updated by: Zhihong LU

The Effect of Different Fluid Therapy on Major Postoperative Morbidity in Patients Undergoing Non-donor Hepatectomy: a Pilot Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • 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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: restrictive
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
Experimental: Restrictive plus preload
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
Experimental: restrictive plus preload plus nitro
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of acute kidney injury
Time Frame: from end of surgery to 7 days after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of acute kidney injury
Time Frame: from end of surgery to discharge from hospital, at an average of 7 days
AKI severity was further classified into three stages: stage 1 was defined as serum creatinine 1.5-1.9 times baseline or an increase of ≥ 0.3 mg/dL (≥ 26.5 μmol/L), or urine output < 0.5 mL/kg/h for 6-12 hours; stage 2 as serum creatinine 2.0-2.9 times baseline, or urine output < 0.5 mL/kg/h for ≥ 12 hours; and stage 3 as serum creatinine 3.0 times baseline, or an increase in serum creatinine to ≥ 4.0 mg/dL (≥ 353.6 μmol/L), or initiation of renal replacement therapy, or urine output < 0.3 mL/kg/h for ≥ 24 hours, or anuria for ≥ 12 hours
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
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
heart failure, myocardial ischemia and new on-set arrythmia
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
The method for calculating blood loss is the volume in the suction canister plus the estimated amount of blood on the gauze
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
0 is extremely unsatisfied, 10 is extremely satisfied
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
0, uncontrolled central venous pressure (CVP), defined as the target CVP of < 5 cmH₂O was achieved for at least 75% of the resection period; 1, defined as the target CVP of < 5 cmH₂O was achieved for 50% -75% of the resection period; 1, defined as the target CVP of < 5 cmH₂O was achieved for less than 50% of the resection period
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
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
hypotension is defined as mean arterial pressure less than 60 mmHg
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
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
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
0=no bleeding; 1=minor bleeding, no aspiration required; 2=minor bleeding, aspiration required; 3 = minor bleeding, frequent aspiration required ; 4 = moderate bleeding, visible only aspiration; 5 = severe bleeding, frequent aspiration required, very hard to perform surgery
at the end of the surgery, ，at an average of 3 hours after anesthesia induction

Collaborators and Investigators

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

Sponsor

Zhihong LU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 2, 2026

Primary Completion (Estimated)

December 2, 2026

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20260222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data will be available with reasonable request to Dr. Zhihong Lu at deerlu23@163.com after Publication

IPD Sharing Time Frame

after publication

IPD Sharing Access Criteria

with reasonable request to Dr. Zhihong Lu at deerlu23@163.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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