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AnesthesiaSHIELD-pilotNCT07440121

Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

A study testing restrictive fluid infusion, preload and nitro in people with Anesthesia and Surgery, run by Zhihong LU.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Surgery
What is being tested?
restrictive fluid infusion, preload and nitro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
2 Apr 2026to 2 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhihong Lu contact

86-13891975018

deerlu23@163.com

About this study

Official title: 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.

Conditions
Anesthesia, Surgery
Being tested
restrictive fluid infusion, preload, nitro
Keywords
fluid therapy, hepatectomy, acute kidney injury
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • restrictive fluid infusionOther

    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

  • preloadOther

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

  • nitroOther

    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.

Study groups in NCT07440121
Study groupRoleWhat they receive
restrictiveExperimentalNot described
Receives: Other: restrictive fluid infusion
Restrictive plus preloadExperimentalNot described
Receives: Other: restrictive fluid infusion; Other: preload
restrictive plus preload plus nitroExperimentalNot described
Receives: Other: restrictive fluid infusion; Other: preload; Other: nitro

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from end of surgery to 7 days after surgery

Secondary outcomes (11)

  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

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

  2. number of patients with post-hepatectomy liver failure

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

  7. dose of norepinephrine

    Measured: 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

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

  9. arterial lactate level

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

  10. arterial lactate level

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start2 Apr 2026 (estimated)
  3. Primary completion2 Dec 2026 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07440121
Sponsor's protocol ID
XJH-A-20260222
Acronym
SHIELD-pilot
Status last verified
Feb 2026
First submitted
21 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified data will be available with reasonable request to Dr. Zhihong Lu at deerlu23@163.com after Publication

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

Questions about this trial

What is this clinical trial studying?

A study testing restrictive fluid infusion, preload and nitro in people with Anesthesia and Surgery, run by Zhihong LU.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhihong Lu (86-13891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of acute kidney injury (time frame: from end of surgery to 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07440121, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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SHIELD-pilot Clinical Trial NCT07440121 | AzTrials