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Not yet recruitingNCT07440121SHIELD-pilotUpdated Feb 27, 2026

Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

An interventional study of restrictive fluid infusion and preload in Anesthesia and Surgery, sponsored by Zhihong LU. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Zhihong LU · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Anesthesia
  • Surgery

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Keywords

  • fluid therapy
  • hepatectomy
  • acute kidney injury
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In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Zhihong LU is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • status over 3
  • existed kidney disease or renal dysfunction
  • severe cardiac or respiratory dysfunction
  • neurological or psychiatric disease
  • class C (score 10-15)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    restrictive

    Other: restrictive fluid infusion

  • Experimental
    Restrictive plus preload

    Other: restrictive fluid infusion · Other: preload

  • Experimental
    restrictive plus preload plus nitro

    Other: restrictive fluid infusion · Other: preload · Other: nitro

Interventions

  • Otherrestrictive 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

  • Otherpreload

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

  • Othernitro

    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.

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What researchers measure

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.

    Time frame: from end of surgery to 7 days after surgery

Secondary outcomes

  1. Severity of acute kidney injury

    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

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

  2. number of patients with post-hepatectomy liver failure

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

  3. number of patients with major cardiac complications

    heart failure, myocardial ischemia and new on-set arrythmia

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

  4. volume of blood loss

    The method for calculating blood loss is the volume in the suction canister plus the estimated amount of blood on the gauze

    Time frame: from start of surgery to end of surgery, at an average of 3 hours

  5. numerical rating scale of surgeon's satisfaction to the surgical field

    0 is extremely unsatisfied, 10 is extremely satisfied

    Time frame: at the end of the surgery

  6. control of central venous pressure during resection

    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

    Time frame: from start of resection to end of removal of the liver lesions ,at an average of 2 hours

  7. dose of norepinephrine

    Time frame: from start of surgery to end of surgery, at an average of 3 hours

  8. frequency of hypotension

    hypotension is defined as mean arterial pressure less than 60 mmHg

    Time frame: from start of surgery to end of surgery, at an average of 3 hours

  9. arterial lactate level

    Time frame: upon completion of surgery,that is, end of incision suture,at an average of 3 hours after anesthesia induction

  10. arterial lactate level

    Time frame: When the liver lesions are removed,at an average of 2 hours after anesthesia induction

  11. surgical field bleeding score

    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

    Time frame: at the end of the surgery, ,at an average of 3 hours after anesthesia induction

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 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. PubMed 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. PubMed 40168322 ↗

Individual participant data

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

Supporting information: Study protocol

Time frame: after publication

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07440121
Lead sponsor
Zhihong LU
Responsible party
Zhihong LU (Professor, Air Force Military Medical University, China) — Sponsor-investigator
First posted
Feb 27, 2026
Start date
Apr 2, 2026 (estimated)
Primary completion
Dec 2, 2026 (estimated)
Completion
Feb 2, 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Zhihong Lu
Contact
deerlu23@163.com
86-13891975018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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