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Plegisol (Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Chloride Intra-Arterial) - Summary

 
 



PLEGISOL SUMMARY

PLEGISOL®

Plegisol (Hospira’s Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation. (See INSTRUCTIONS FOR USE.)Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; magnesium (Mg++) 32 mEq; potassium (K+) 16 mEq; sodium (Na+) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO3‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Plegisol with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.

Plegisol (Calcium chloride/Magnesium chloride/Potassium chloride/Sodium Chloride INTRA-ARTERIAL) is indicated for the following:

Plegisol (Hospira’s Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.


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NEWS HIGHLIGHTS

Published Studies Related to Plegisol (Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Chloride Intra-Arterial)

Creatine phosphate (Neoton) as an additive to St. Thomas' Hospital cardioplegic solution (Plegisol). Results of a clinical study. [1991]
Experimentally, creatine phosphate (CP) added to St... Serum CK and CK-MB values were similar throughout the sampling period in both groups of patients; one patient in the control group had raised CK-MB levels postoperatively, but perioperative infarction was not indicated by the electrocardiogram.(ABSTRACT TRUNCATED AT 250 WORDS).

Comparison of standard (non-oxygenated) vs. oxygenated St. Thomas' Hospital cardioplegic solution No. 2 (Plegisol). [1990]
Recent studies have suggested that oxygenation of crystalloid cardioplegic solutions improves myocardial preservation. To assess whether oxygenation of St... CK-MB values showed no difference at any sampling time between the 2 groups of patients; a mean peak CK-MB of 35 IU/l occurred 2 h postoperatively.(ABSTRACT TRUNCATED AT 250 WORDS).

[The experimental study of myocardial protection for warm myocardial ischemia in an isolated rat heart: the effect of a calcium antagonist] [1996.02]
Although the protective effects of the calcium antagonists on ischemic and reperfused myocardium have been investigated, there have been only a few reports regarding their efficacy in relation to the degree of ischemic myocardium. This study was undertaken to investigate the efficacy of diltiazem, a calcium antagonist, in relation to the degree of ischemic myocardial injury in an isolated working rat heart...

Effect of cardioplegic preservation on intracellular calcium transients. [1991.10]
Intracellular Ca2+ ([Ca2+]i) plays a pivotal role in the regulation of cardiac function. We investigated the effect of cardioplegic preservation on [Ca2+]i transients in the isolated and perfused guinea pig heart loaded with a fluorescent Ca2+ indicator (fura-2)... These results may provide new insight into the mechanism of cardioplegic preservation on the basis of [Ca2+]i transients.

Superior protective effect of low-calcium, magnesium-free potassium cardioplegic solution on ischemic myocardium. Clinical study in comparison with St. Thomas' Hospital solution. [1991.04]
The protective effect of low-calcium, magnesium-free potassium cardioplegic solution on ischemic myocardium has been assessed in adult patients undergoing heart operations. Postreperfusion recovery of cardiac function and electrical activity was evaluated in 34 patients; 16 received low-calcium, magnesium-free potassium cardioplegic solution (group I) and 18 received St...

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Clinical Trials Related to Plegisol (Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Chloride Intra-Arterial)

Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis [Recruiting]
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

Custodiol-HTK Solution as a Cardioplegic Agent [Recruiting]

Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol [Recruiting]
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e. g., myocardial infarction).

Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery [Recruiting]
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.

Adenosine Cardioplegia; Improved Cardioprotection? [Recruiting]
60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St. Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1. 2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.

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Page last updated: 2007-02-12

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