Health TrialsbyHealthPanel

Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

ConditionsAnesthesiaSurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhihong LU

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

scheduled for elective hepatectomy under general anesthesia

age ≥18 yrs old

Disqualifiers

American society of anesthesiologists status over 3

existed kidney disease or renal dysfunction

severe cardiac or respiratory dysfunction

neurological or psychiatric disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • restrictive fluid infusion

    Other intervention

    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 intervention

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

  • nitro

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: restrictiveExperimental treatment 1 intervention
Group B: Restrictive plus preloadExperimental treatment 2 interventions
Group C: restrictive plus preload plus nitroExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhihong LU

Lead sponsor

Air Force Military Medical University, China

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: