Pre-transfusion Furosemide in Patients at High Risk of Transfusion-associated Circulatory Overload - The Transfusion-Associated Circulatory Overload Best Eliminated With Lasix (TACO-BEL) Study: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Number of patients enrolled
研究概览
简要总结
This is a pilot double-blinded placebo-controlled randomized controlled trial (RCT) to evaluate the feasibility of conducting a multicenter, randomized, placebo-controlled trial to assess the efficacy of pre-transfusion furosemide in preventing transfusion-associated circulatory overload (TACO) in hemodynamically stable inpatients aged 65 years or older receiving a single unit red blood cell transfusion. Patients will be randomly allocated to receive either furosemide (20mg intravenous) or placebo (saline) within 60 minutes of starting a red blood cell (RBC) transfusion. Randomization will be stratified by centre and renal dysfunction (creatinine clearance ≥ 60 mL/min or < 60 mL/min). This is a blinded trial: patients, care-providers (physicians and nurses), data collectors, outcome adjudicators, and data analysts will not be aware of group allocation.
详细描述
The investigators proposed this pilot study to assist us in determining the feasibility of conducting a definitive multicenter randomized trial across Canada.
Rationale:
The rationale for this study includes: (1) TACO is the leading cause of morbidity and mortality due to transfusion; (2) risk factors for TACO include older age, renal dysfunction and positive fluid balance; (3) furosemide is a diuretic commonly prescribed for fluid overload; (4) furosemide can decrease pulmonary artery pressures; and (5) clinical uncertainty as to the effect of furosemide in preventing TACO. The investigators will enroll 80 patients in this pilot study at two centers.
Hypothesis:
The investigators hypothesize that 80 patients can be enrolled in the trial within a 2-month period
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Receiving a single unit red blood cell transfusion
排除标准
- •Active bleeding (active visible bleeding, required 2 or more RBC units in the preceding 24 hours, drop in Hb > 20 g/L in the preceding 24 hours);
- •Hemodynamically unstable (systolic blood pressure < 90 mmHg or on inotropes);
- •Anticipated major surgical procedure within 24 hours of enrolment;
- •Presence of hyponatremia (Na < 130 mmol/L);
- •Presence of hypokalemia (K < 3.5 mmol/L);
- •Dialysis or creatinine clearance < 30 mL/min;
- •Order for platelet or plasma transfusion at same time;
- •Allergy to furosemide;
- •Risk of withholding furosemide felt by attending physician to place patient at excessive risk of harm;
- •Previously enrolled in the study;
- •Plan for discharge on the day of randomization;
- •Unable to provide informed consent.
研究组 & 干预措施
Placebo
Normal saline
干预措施: Normal Saline (Drug)
Furosemide
Diuretic
干预措施: Furosemide (Drug)
结局指标
主要结局
Number of patients enrolled
时间窗: 2 months period
次要结局
- Proportion of patients screened meeting eligibility criteria(2 months)
- Proportion of eligible patients consenting to participate(2 months)
- Proportion of patient receiving the allocated treatment(2 months)
- Proportion of treated patients completing follow-up assessment(2 months)
- Proportion of patient in which blinding was maintained throughout study(2 months)
- Vital Signs(Baseline and 6 hours post transfusion)
- Positive end-expiratory pressure(Baseline and 6 hours post transfusion)
- Inspiratory oxygen(Baseline and 6 hours post transfusion)
- Incidence of TACO within 6 hours from completion of transfusion(within 6 hours)
- Severity of TACO-graded as per the Public Health Agency of Canada's Transfusion Transmitted Injuries Surveillance System(within 6 hours)
- Validation of TACO as per criteria adopted from the US Center for Disease Control(within 6 hours)
- Change in plasma brain natriuretic peptide(BNP)(Baseline and Day 1)
- Net fluid balance at 24 hours from start of transfusion- all intravenously-administered fluids (including the transfused blood product and the study intervention)(Within 24 hours)
- Proportion of patients developing hyponatremia or hypokalemia by Day 1(By Day 1)
- Proportion of patients developing hypotension(Within 24 hours)
- Proportion of patients developing acute kidney injury(Within 24 hours)
- Need for increased supplemental oxygen is defined as any increase in oxygen flow ≥ 1 L/hr or (fraction of inspired oxygen)FiO2 ≥ 5% of 1 hour duration or longer, prompted by either patient symptoms or a fall in oxygen saturation(SpO2) ≥ 5%(Within 24 hours)
- Need for inotropic support is defined as the initiation of a continuous infusion of dopamine, dobutamine, epinephrine, or norepinephrine(Within 24 hours)
- Need for additional diuretic or vasodilatory therapy is defined by the prescription of non-study furosemide, hydrochlorothiazide, metolazone, or either transdermal or intravenous nitroglycerin(Within 24 hours)
- Occurrence of acute coronary syndrome or new arrhythmia(within 7 days)
- Mortality during hospital stay(Upto 30 days)
- Length of hospital stay(From date of admission until the date discharge from an acute care hospital or date of death from any cause, whichever came first, assessed up to 30 days.)