Meta AnalysisID 4356
羟乙基淀粉对比晶体液用于腹内手术患者目标导向容量替代治疗的系统评价和个体患者数据Meta分析
CRD42021229203
In adult patients undergoing goal-directed fluid therapy for major abdominal surgery, does the use of hydroxyethyl starch compared to crystalloid for volume replacement therapy increase the risk of postoperative acute ki
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Record Fields
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- Meta Analysis Id
- 4356
- Evidence Id
- 12914
- Core Evidence Id
- 12914
- Source Meta Analysis Id
- 4323
- Herb2 Meta Analysis Id
- HBMA004323
- Crd Id
- CRD42021229203
- Title
- Systematic review and individual patient data meta-analysis on hydroxyethyl starch versus crystalloid for goal-directed volume replacement therapy in patients undergoing intraabdominal surgery.
- Review Question
- In adult patients undergoing goal-directed fluid therapy for major abdominal surgery, does the use of hydroxyethyl starch compared to crystalloid for volume replacement therapy increase the risk of postoperative acute kidney injury?
- Study Type Included
- We will only include randomized controlled trials.
- Condition Being Studied
- Postoperative complications are associated with high morbidity and mortality. Administration of intravenous fluid therapy is a critical aspect of care during major abdominal surgery. The use of crystalloid or colloid for volume replacement therapy (to restore intravascular volume in case of hypovolemia) is a highly debated issue in perioperative medicine and intensive care medicine. Evidence from trials in patients with sepsis and in critically ill patients has shown that HES use is associated with acute kidney injury with no patient benefits. In 2013, the European Medicines Agency restricted the use of HES for critically ill patients but retained approval for HES to treat blood loss–related hypovolemia. HES are used for fluid replacement therapy in patients undergoing major surgery because of their hypothetical ability to provide faster hemodynamic stabilization than crystalloid solutions during acute hypovolemia though allowing better fluid balance. Alternatively, the use of crystalloids is not devoid of risk and can be associated with excessive fluid administration, resulting in an increased risk of acute kidney injury and death.
- Participant
- The participants will be adult (> 18 years) surgical patients undergoing major abdominal surgery (open or laparoscopic-assisted abdominal surgery) using an individualized goal-directed fluid therapy protocol to guide fluid administration. We will not include critically ill patients or patients with chronic kidney disease (defined as glomerular filtration rate <30ml/min/1.73 m2 or requiring renal replacement therapy for end-stage kidney disease). Patients with renal graft will not be enrolled.
- Animal
- Human Disease Modelled
- Intervention
- Hydroxyethyl starch (HES) infusion: Perioperative infusion of 6% HES with a molecular mass of 130 kDa (designated as 6% HES 13/0.4 or 6% HES 130/0.42) during surgery and early postoperative period (24 to 48h) as fluid replacement therapy using an individualized hemodynamic algorithm (based on cardiac output or stroke volume assessment).
- Comparator Control
- Crystalloid infusion: Perioperative infusion of balanced crystalloid or 0.9% saline solution (during surgery and early postoperative period: 24 to 48h) as fluid replacement therapy using an individualized hemodynamic algorithm (based on cardiac output or stroke volume assessment).
- Main Outcome
- The primary outcome will be postoperative acute kidney injury (AKI), defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, within 7 days of the index surgery. Measures of effect AKI of stage 1 or higher according to KDIGO criteria
- Outcome Measure
- Additional Outcome
- - AKI defined according to KDIGO criteria (stages 1 to 3) persistent ≥7 days after the index surgery (through day 28 or 30 after surgery) - Renal failure requiring renal replacement therapy through day 28 or 30 after surgery - Maximum serum creatinine level through day 28 or 30 after surgery - Hospital mortality - Hospital length of stay at hospital discharge Measures of effect - KDIGO stages 1 to 3 - Percentage of patients receiving renal replacement therapy - Maximum plasmatic serum creatinine through day 28 or 30 after surgery - Hospital mortality - Duration at hospital stay
- Study Method
- Individual patient data (IPD) meta-analysis, Systematic review
- Keyword
- Crystalloid Solutions; Goals; Humans; Hydroxyethyl Starch Derivatives; Plasma Substitutes
- Contact
- Lucie Aupetitgendre [email protected]
- Organisational Affiliation
- Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, France
- Funding Source
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- France
- Review Stage
- Review Ongoing
- First Submission Date
- 2021-01-04
- Registration Date
- 2021-02-02
- Anticipated Start Date
- 2021-02-01
- Anticipated Completion Date
- 2021-09-01
- Title Cn
- 羟乙基淀粉对比晶体液用于腹内手术患者目标导向容量替代治疗的系统评价和个体患者数据Meta分析
- Title En
- Systematic review and individual patient data meta-analysis on hydroxyethyl starch versus crystalloid for goal-directed volume replacement therapy in patients undergoing intraabdominal surgery.
- Bilingual Status
- complete