Cerebral salt wasting syndrome in patients with tuberculous meningitis Infections and Infestations
Conditions
Interventions
Once the diagnosis of cerebral salt wasting syndrome was ascertained in the patients with tuberculous meningitis, the patients were randomized to propranolol or placebo (saccharine) using simple rando
thereafter, gradually tapered within 2 weeks. The placebo group received saccharine tablet in the similar manner.
Sponsors
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged between 15 to 70 years with tuberculous meningitis and having cerebral salt wasting syndrome (CSW) Diagnostic criteria of tuberculous meningitis Essential criteria: The clinical features of meningitis (fever, headache, vomiting) for more than 2 weeks Supportive criteria: 1. Cranial imaging: CT/MRI evidence of excaudate, hydrocephalous, granulomas in isolation or in combination 2. Cerebrospinal fluid: cells 10-500/mmb, lymphocytic predominance, protein >1 g/liter 3. Evidence of extra CNS active tuberculosis 4. Exclusion of alternative diagnosis of meningitis The diagnosis of CSW was based on the following essential and supportive criteria Essential criteria, all are mandatory 1. Polyuria (>3 l/day for two consecutive days) 2. Serum sodium <135 mEq/L in two consecutive tests 24 hours apart 3. Absence of secondary causes of hyponatremia such as renal, hepatic or cardiac failure, endocrinal disorder, natriuretic drugs etc Supportive criteria: three out of five are needed 1. Clinical incidence of hypovolemia: dry skin, hypotension, tachycardia or postural hypotension 2. Consistent fluid deficit on intake output chart 3. Laboratory evidence of dehydration such as elevated hematocrit, hemoglobin, albumin and blood urea 4. Central venous pressure less than 6 cm of water 5. Urinary sodium more than 40 mEq/L or urine osmolality more than 300 mOsmol/L on two consecutive days
Exclusion criteria
Exclusion criteria: 1. Patients with endocrinal disorder, organ (renal, liver, heart) failure, vasculities, renal tubular acidosis, malignancy, pregnancy, lactation, on chemotherapy, radiotherapy, inotrope, dopaminergic, antidopaminergic, diuretics, carbamazepine, mannitol or aminoglycosides 2. Above 70 years and below 15 years of age 3. Denial of consent 4. Patients requiring mechanical ventilation or cardiopulmonary resuscitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days for normalization of serum sodium: serum sodium levels were measured every third day for up to 1-month post-randomization, at 1 month, 3 months and 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days to achieve 500 ml positive fluid balance (Intake- output >500 ml). Daily fluid balance (intake and output over 24 hours) was recorded to monitor fluid status. 2. Number of days to have <3 L urinary output. Daily fluid balance (intake and output over 24 hours) was recorded to monitor fluid status. 3. Mortality recorded at 1 month 4. Side effects recorded during hospitalization and at follow-up visits at 1 month, 3 months, and 6 months 5. Functional outcome assessed using a modified Rankin Scale (mRS) and categorized as good (mRS score < 3) and poor (mRS score 3 to 6) at 3 and 6 months | — |
Countries
India
Contacts
Public ContactJayantee Kalita
Outcome results
None listed