The currently recommended therapeutic approaches to the treatment of hyponatremia (low serum sodium levels) in hospitalised subjects are under review as newer and more effective therapeutic options are developed.
Hyponatremia is the most common electrolyte disorder seen in the clinical setting. It is associated with a variety of underlying diseases and conditions affecting approximately 10-15 per cent of hospitalised subjects at some time during their hospital stay.
Hyponatremia is often characterised as a state of water overload that is out-of-proportion to the amount of sodium contained in the blood. In these cases, interventions that promote renal excretion of water without associated sodium loss are considered appropriate therapy.
Under the terms of the agreement, Covalent will provide consultative input into the overall design of the Registry and Project Management as well as operational support that includes study site management, data management, biostatistical services, and medical writing.
Covalent will also work closely on this Registry with its partner, Sudler & Hennessey, providing communications, medical education, and electronic media support to the program.
Revenue recognition, which will begin in this quarter, will be on a proportional performance basis over the life of the contract as services are performed.
"This Registry is an example of the value of the Strategic Partnership with Sudler & Hennessey in which Covalent's excellence in clinical trial consulting, design, and operations is combined with Sudler & Hennessey's marketing, medical education, and communications expertise to help address patient care issues," said Kenneth Borow, >Covalent Group's President and Chief Executive Officer.
Hyponatremia is important clinically since acute severe cases can cause substantial morbidity and mortality. Indeed mild cases can progress to more dangerous levels during management of other medical disorders and general mortality appears to be higher in subjects with even asymptomatic hyponatremia.
Overly rapid correction of chronic hyponatremia can produce severe neurologic problems and death.
The Hyponatremia Registry is designed to help meet the need for more thorough evidence-based real-world patient safety and treatment data in hospitalised subjects with low serum sodium levels.
It will help create insights into the effectiveness of traditional as well as innovative therapeutic interventions, drug utilisation patterns, quality-of-life measurements, and healthcare resource utilisation/cost analyses as they relate to hyponatremia in hospitalised subjects.
In addition, the Registry will provide communication and medical education opportunities for individuals interested in learning more about the diagnosis and treatment of hyponatremia.
The Registry will have ongoing independent oversight performed by acknowledged experts in various therapeutic areas relating to serum electrolyte abnormalities.