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...
Clinical Trials Related to Plegisol (Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Chloride Intra-Arterial)
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633AM1) [Recruiting]
The purpose of this study is to determine whether acadesine is effective in reducing the
cardiovascular and cerebrovascular adverse events in high-risk patients undergoing CABG
surgery.
Intermittent Cold Blood Vs Crystalloid Cardioplegia in Aortic Valve Surgery [Recruiting]
Controversies still exists concerning the overall clinical effects of blood-based vs.
crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest.
Both techniques are used world-wide. No larger prospectively randomized studies comparing the
two methods have been reported. The aim of this study is to collect a large number of
clinical data to create a proper basis for evaluation of the two techniques.
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB) [Recruiting]
Conventional cardiac operations are performed with median sternotomy, which is related to
great wound, morbidities, longer duration in hospital and most significantly, cosmetic
problems. The investigators invested a new minimally invasive cardiac operation method
totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators'
hypothesis is that this new minimally method could provide better cosmetic effects to the
patients, and also relate to shorter postoperative hospital stay and better recovery.
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Page last updated: 2007-02-12
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