Anesthesia, Surgery
Conditions
Keywords
fluid therapy, hepatectomy, acute kidney injury
Brief 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.
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.
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of acute kidney injury | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of acute kidney injury | 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 |
| number of patients with post-hepatectomy liver failure | from end of surgery to discharge from hospital, at an average of 7 days | — |
| number of patients with major cardiac complications | from end of surgery to discharge from hospital, at an average of 7 days | heart failure, myocardial ischemia and new on-set arrythmia |
| volume of blood loss | 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 |
| numerical rating scale of surgeon's satisfaction to the surgical field | at the end of the surgery | 0 is extremely unsatisfied, 10 is extremely satisfied |
| control of central venous pressure during resection | 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 |
| dose of norepinephrine | from start of surgery to end of surgery, at an average of 3 hours | — |
| frequency of hypotension | 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 |
| arterial lactate level | upon completion of surgery，that is, end of incision suture，at an average of 3 hours after anesthesia induction | — |
| surgical field bleeding score | 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 |
Contacts
CONTACTZhihong Lu
Outcome results
None listed