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NCT Number: NCT07440121

Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

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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Key information

Conditions

Anesthesia Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Surgery Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

preload

Other

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  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

    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

  4. 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

  5. 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

  6. 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

  7. dose of norepinephrine

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

  8. 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

  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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Lu

CONTACT

[email protected]

86-13891975018

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: SHIELD-pilot

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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