Preoperative Sodium Glucose Cotransporter 2 Inhibitors for Prevention of Postoperative Acute Kidney Injury in Cardiac Surgery Patients - a Randomized, Placebo-controlled, Multi-centre, Phase IV Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 784
- 试验地点
- 6
- 主要终点
- AKI
研究概览
简要总结
Multi-centre, triple-blinded (patients, physicians, investigators), parallel-group, balanced (1:1), stratified (sex, type 2 diabetes mellitus), randomized, controlled (placebo), phase IV clinical trial to investigate the potential of preoperative initiation (from day 1 before surgery) and perioperative continuation (until day 2 after surgery) of the SGLT2 inhibitor dapagliflozin 10 mg once daily to prevent AKI according to the KDIGO criteria (an increase in serum creatinine by 0.3 mg/dl (26.5 mmol/l) within 48 hours; or an increase in serum creatinine to 1.5 times baseline, within 7 days; or a urine output <0.5 ml/kg/h for >6 hours) in adult (>18 years old) patients undergoing cardiopulmonary bypass surgery.
详细描述
Background of the study:
Acute kidney injury is one of the most common complications after cardiac surgery. The new glucose-lowering therapy, sodium glucose transport protein 2 inhibitors (SGLT2i) possess renoprotective properties in people with chronic kidney disease in the presence or absence of type 2 diabetes. Large cardiovascular outcome trials in patients with diabetes observed a lower incidence of acute kidney injury. However, these studies were not powered to investigate this nor did acute kidney injury concern an adjudicated endpoint.
Objective of the study:
To investigate the potential of preoperative initiation (from day 1 before surgery) and perioperative continuation (until day 2 after surgery) of the SGLT2 inhibitor dapagliflozin 10 mg once daily to prevent AKI according to the KDIGO criteria in patients undergoing cardiopulmonary bypass surgery.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years-old
- •Undergoing elective cardiac surgery.
- •Providing informed consent
排除标准
- •Current treatment with SGLT2 inhibitors
- •Reduced kidney function at baseline with eGFR < 20 ml/min at time of inclusion
- •Diabetes Mellitus Type 1
- •History of diabetic keto acidosis
- •Diabetes Mellitus Type 2 with BMI<25 for people with type 2 diabetes who are using multiple daily insulin injections (both short and long-acting insulin)
- •Systolic blood pressure < 100 mmHg at time of inclusion
- •Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. "S1-4" according to the Amsterdam UMC classification
- •Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- •Known or suspected allergy to trial products or other drugs in the same class
研究组 & 干预措施
Intervention
Dapagliflozin 10 mg
干预措施: Dapagliflozin 10 MG Oral Tablet [Farxiga] (Drug)
Placebo
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AKI
时间窗: Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).
Incidence of Acute Kidney Injury (AKI) occurring in 7 days after surgery, according to KDIGO criteria, defined as an increase in serum creatinine by 0.3 mg/dl (26.5 mmol/l) within 48 hours; or an increase in serum creatinine to 1.5 times baseline, within 7 days; or a urine output \<0.5 ml/kg/h for \>6 hours.
次要结局
- LoS-Hos(Recorded on day of discharge from the hospital, assessed up to 30 days.)
- MACE(Within 30 days postoperatively.)
- QoR 1: DAH30(Recorded at 30 days postoperatively.)
- QoR 3: EQ5D5L(Recorded at 30 days postoperatively.)
- Hypoglyceamia(From admission to hospital until day 3 postoperatively.)
- Cardiac biomarker 1: Troponin(From transfer to ICU until 48 hours postoperatively.)
- LoS-ICU(Recorded on day of discharge from ICU, assessed up to 30 days.)
- QoR 2: WHODAS2(Recorded at 30 days postoperatively.)
- AKI-3(Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).)
- eGFR(Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).)
- AF(Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).)
- MAKE(Within 30 days postoperatively.)
- Safety outcomes(Within 30 days postoperatively.)
- Health care costs(Recorded at 30 days postoperatively.)
- Haemodynamics 2: MAP(From start of anaesthesia until discharge from the Intensive Care Unit, assessed up to 72 hours.)
- Haemodynamics 1: HR(From start of anaesthesia until discharge from the Intensive Care Unit, assessed up to 72 hours.)
- Productivity costs(Recorded at 30 days postoperatively.)
- Hyperglyceamia(From admission to hospital until day 3 postoperatively.)
- Haemodynamics 3: CO(From start of anaesthesia until discharge from the Intensive Care Unit, assessed up to 72 hours.)
- Urinary Oxygenation (Amsterdam UMC only)(From end to start of surgery and from transfer to ICU until discharge or 48 hours postoperatively.)
- Cardiac biomarker 2: CK-MB(From transfer to ICU until 48 hours postoperatively.)
- Postoperative LVF(Within 30 days postoperatively.)
研究者
Abraham Hulst, MD, PhD
Principal Investigator
Amsterdam UMC