Comparison of Potassium Binders in the ER
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in blood potassium level
研究概览
简要总结
Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.
详细描述
Adult patients presenting to the Emergency Room or currently hospitalized at UC Irvine (not in ICU level of care) with plasma potassium >5.5 mEq/L (who meet inclusion/exclusion criteria and provide written informed consent) will be randomized to a one-time dose of one of the following oral medications:
- Sodium polystyrene sulfate (SPS)
- Patiromer (Veltassa)
- Sodium zirconium cyclosilicate (Lokelma)
- Nonspecific laxative: polyethylene glycol 3350 (MiraLax)
Participants will receive standard-of-care hyperkalemia therapy as well.
Blood potassium will be checked at 2 and 4 hours after dose of study drug. Participants will complete a symptom and palatability questionnaire at 4 hours.
The purpose of this research study is to determine the effects of various potassium binders (SPS, patiromer, zirconium) vs a non-specific laxative (MiraLax) in hospital patients found to have elevated blood potassium > 5.5 mEq/L. Hyperkalemia is a fairly common electrolyte disorder with varying levels of severity. Moderate hyperkalemia is in the range 5.5-5.9 mEq/L while severe hyperkalemia is ≥6.0 mEq/L or if patient is symptomatic: muscle weakness/paralysis or with EKG changes (e.g., peaked T waves, widening QRS, arrhythmias including ventricular fibrillation or asystole). Hyperkalemia is most commonly associated with kidney insufficiency, metabolic acidosis, and the use of medications such as renin-angiotensin-aldosterone system inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and ER physicians are blinded to study drug allocation.
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
- •Plasma potassium > 5.5 mEq/L
- •Age ≥18 years
- •Patient able to provide written informed consent
排除标准
- •Recent bowel surgery
- •Ileus or bowel obstruction
- •Pseudohyperkalemia signs and symptoms, such as excessive fist clenching, hemolyzed blood specimen, severe leukocytosis or thrombocytosis
- •Pregnancy
- •Active psychiatric disorder
- •Diabetic ketoacidosis or hyperkalemia caused by any condition for which a therapy directed against the underlying cause of hyperkalemia would be a better treatment option
- •Dialysis session expected within 4 hours after randomization
- •History of hypersensitivity to sodium polystyrene sulfonate resin or patiromer
- •Concurrent use of sorbitol (due to increased risk of intestinal necrosis when used with sodium polystyrene sulfonate)
研究组 & 干预措施
Polyethylene glycol 3350 (MiraLax)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
干预措施: Polyethylene Glycol 3350 (Drug)
Sodium polystyrene sulfonate (Kayexalate)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
干预措施: Sodium Polystyrene Sulfonate Oral Suspension [SPS] (Drug)
Patiromer (Veltassa)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
干预措施: Patiromer (Drug)
Sodium zirconium cyclosilicate (Lokelma)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
干预措施: Sodium zirconium cyclosilicate (Drug)
结局指标
主要结局
Change in blood potassium level
时间窗: Plasma potassium level measured at 2 and 4 hours after study drug was administered
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)
时间窗: Plasma potassium level measured at 2 and 4 hours after study drug was administered
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
次要结局
- Length of ER or hospital stay(Up to 60 days after study drug was administered)
- Dialysis yes/no within 8 hours(Within 8 hours of study drug being administered)
- Change in calcium, phosphorus and magnesium(Measured at 2 and 4 hours after study drug was administered)
- Palatability and side effects (patient subjective rating)(4 hours after study drug was administered)
- Length of ER or Hospital Stay(Up to 60 days after study drug was administered)
- Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)(Measured at 4 hours after study drug was administered)
- Number of Participants Reporting GI Side Effects(4 hours after study drug was administered)
- Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered(Within 8 hours of study drug being administered)
研究者
Wei Ling Lau
Associate Professor in Nephrology, Dpt of Medicine
University of California, Irvine