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Hyperkalemia clinical trials

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NCT ID: NCT02672930 Completed - Clinical trials for Chronic Renal Failure

How Much Reliable iv Calcium for the Treatment of Hyperkalemia?

Start date: July 2015
Phase:
Study type: Observational [Patient Registry]

Hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially, avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the literature. So the aim of this study was to evaluate administration of iv calcium efficiency on vital signs and ECG.

NCT ID: NCT02609841 Completed - Hyperkalemia Clinical Trials

POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study

PORTEND
Start date: September 2015
Phase: N/A
Study type: Interventional

This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60, with the remainder of the subjects on 1K or 2K dialysate.

NCT ID: NCT02607085 Completed - Hyperkalemia Clinical Trials

REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study

REVEAL-ED
Start date: October 31, 2015
Phase: N/A
Study type: Observational

This study evaluates the management of subjects with Standard of Care (SOC) when admitted to the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics and medical history data, including previous ED visits and/or hospital admissions for hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an intervention/treatment for hyperkalemia will have study-related potassium values determined at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no intervention/treatment during the initial 4-hour period will have a study-related potassium value determined 4 hours after the baseline potassium measurement. Available data obtained as part of SOC management will include physical examinations, vital signs, fluid intake and urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the subject's chief complaint upon admission to the ED, the possible cause of the subject's hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall discharge summary will also be collected.

NCT ID: NCT02483702 Completed - Clinical trials for Graft Versus Host Disease

Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

Start date: August 2015
Phase: N/A
Study type: Interventional

Blood transfusions are required for patients undergoing a craniosynostosis repair due to the significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks involved including elevated potassium levels and graft versus host disease (TA-GVHD). Irradiated blood is able to destroy the leukocytes responsible for TA-GVHD, but it adversely causes elevated extracellular potassium due to hemolysis of the RBC's. When this blood is transfused, it may introduce too much extracellular potassium (> 6.5 meq/L) into the patient causing interference with the heart's conduction system significantly increasing the risk for hemodynamic changes, cardiac arrhythmias, and cardiac arrest. Hyperkalemia from rapid transfusions occurs much more frequently than TA-GVHD; however, both complications are under-reported. The study aims to evaluate the risk of irradiated versus non-irradiated blood in patients under the age of 6 months undergoing a craniosynostosis repair. This will be done by comparing the levels of extracellular potassium pre-transfusion, during transfusion, immediately after transfusion, and 30 minutes after the completion of transfusion. The investigators hypothesize that the patients who receive irradiated blood will have an increased extracellular potassium level compared to those who receive non-irradiated blood.

NCT ID: NCT02163499 Completed - Hyperkalemia Clinical Trials

Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Start date: June 30, 2014
Phase: Phase 3
Study type: Interventional

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

NCT ID: NCT02107092 Completed - Hyperkalemia Clinical Trials

Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.

Start date: May 31, 2014
Phase: Phase 3
Study type: Interventional

Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.

NCT ID: NCT02088073 Completed - Hyperkalemia Clinical Trials

Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.

Start date: March 31, 2014
Phase: Phase 3
Study type: Interventional

It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).

NCT ID: NCT02065076 Completed - Hyperkalemia Clinical Trials

Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients

SKIP
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.

NCT ID: NCT02020317 Completed - Hyperkalemia Clinical Trials

Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions

Start date: January 2014
Phase: N/A
Study type: Interventional

To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.

NCT ID: NCT01810939 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

OPAL
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.