Effect of endocrine input on time for hyponatraemia correction
Research type
Research Study
Full title
Prospective, single-centre study of the effect of intensive endocrine input versus routine clinical care on the time for correction of hyponatraemia and on patient outcomes in hospitalised patients with hyponatraemia due to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
IRAS ID
121732
Contact name
Pierre-Marc Bouloux
Contact email
Sponsor organisation
Joint Research Office
Research summary
This is a study of hospitalised patients with hyponatraemia, low amount of sodium in the blood, due to SIADH (syndrome of inappropriate antidiuretic hormone secretion). These patients produce large amounts of antidiuretic hormone which leads to water excess and low blood sodium concentration due to dilution. This study will examine if expert endocrine input could improve patient outcomes.
Hyponatraemia is very common in hospitalised patients. Patients with hyponatraemia have various symptoms, have a high possibility to die during admission and tend to stay for a long time in the hospital. Several studies have shown that hyponatraemia is frequently suboptimally investigated and managed. This is the first study exploring the potential benefits of expert input to hyponatraemic patients. This study could potentially benefit patients if it shows reduction in mortality or duration of hospital stay.
This single-centre study will include inpatients at the Royal Free Hospital with blood sodium levels ≤ 128 mmol/l due to SIADH over a 2-month period. The Investigators, Endocrinologists with special interest in this condition, will provide expert input to all hyponatraemic patients with respect to the assessment and management of hyponatraemia in close liaison with the caring clinical team. The investigators will not use any novel investigations tools or therapeutic modalities; they will follow best clinical practice and will use diagnostic tests and therapeutic modalities which are well established in clinical practice. The comparator group, representing routine clinical care, will be patients with the same clinical problem over the 2-month period preceding the study period.
The primary hypothesis is that expert endocrine input could reduce the time required for correction of hyponatraemia. The secondary hypothesis is that reduced duration of exposure to low sodium levels could reduce inpatient mortality and shorten length of hospital stay.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
14/LO/0268
Date of REC Opinion
3 Apr 2014
REC opinion
Further Information Favourable Opinion