Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | December 2016 |
| Contact: | Courtney B Sweet, PharmD |
| Email: | sweetc@wvuhealthcare.com |
| Phone: | 304-598-4148 |
Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major
complication of premature birth and is associated with a significant increased risk of
complications including death. Diuretics have been used for decades in babies with BPD and
are considered a standard of care. Patients receive electrolyte supplementation to replace
the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics
at removing extra fluid, but it is different from chlorothiazide and furosemide because
instead of removing potassium, it actually can increase potassium levels in our body.
Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,
reduce the electrolyte supplementation needed. However, studies have suggested that preterm
babies aren´t developed enough to appropriately respond to spironolactone. Also, one study
has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on
whether or not patients receive electrolyte supplementation. This study will examine whether
there is a difference in the amount of electrolyte supplementation between patients
receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators
hypothesize there will be no difference in the amount of electrolyte supplementation between
the two groups.
complication of premature birth and is associated with a significant increased risk of
complications including death. Diuretics have been used for decades in babies with BPD and
are considered a standard of care. Patients receive electrolyte supplementation to replace
the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics
at removing extra fluid, but it is different from chlorothiazide and furosemide because
instead of removing potassium, it actually can increase potassium levels in our body.
Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,
reduce the electrolyte supplementation needed. However, studies have suggested that preterm
babies aren´t developed enough to appropriately respond to spironolactone. Also, one study
has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on
whether or not patients receive electrolyte supplementation. This study will examine whether
there is a difference in the amount of electrolyte supplementation between patients
receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators
hypothesize there will be no difference in the amount of electrolyte supplementation between
the two groups.
Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major
complication of premature birth and is associated with significant morbidity and mortality.
Bronchopulmonary dysplasia most commonly affects preterm infants who have required prolonged
aggressive mechanical ventilation and/or oxygen supplementation. Risk factors associated
with BPD include degree of prematurity, infection, mechanical ventilation, oxygen
concentration, and nutritional status. Despite significant advances in the care of preterm
infants and improved survival, the incidence of BPD has been fairly static over the past
decade.
Diuretics and fluid restriction are considered a mainstay of therapy in the management of
BPD to combat interstitial alveolar edema. Short courses of furosemide followed by long-term
therapy using a thiazide diuretic with concurrent spironolactone have shown improvement in
pulmonary function and better outcomes. Double-blinded, randomized, placebo-controlled
trials have shown improvement in pulmonary compliance, airway resistance, infants alive at
discharge, and a decrease in fraction of inspired oxygen and need for furosemide boluses.
Spironolactone is a competitive aldosterone receptor antagonist that acts on the distal
convoluted tubule and collecting duct to facilitate sodium excretion while conserving
potassium and hydrogen ions. Since only a minimal amount of sodium filtered by the
glomerulus reaches the distal tubule, spironolactone is considered a weak diuretic.
Spironolactone is primarily used with chlorothiazide for its potassium-sparing effect to
reduce the need for electrolyte supplementation. There has only been one prospective,
randomized, double-blind, placebo-controlled study comparing chlorothiazide with or without
the addition of spironolactone in premature infants with chronic lung disease. This study
demonstrated no difference between the groups in the need for electrolyte supplementation,
electrolyte balance, or pulmonary function. In addition, preterm infants' distal tubules may
respond inadequately to aldosterone; thereby, limiting the role of spironolactone in this
patient population.
In the neonatal population, spironolactone is primarily used in addition with chlorothiazide
for its potassium-sparing effects to reduce the need for electrolyte supplementation.
However, evidence and current practice suggests the majority of patients still receive
electrolyte supplementation. One study evaluated spironolactone's effect on the need for
electrolyte supplementation, but there is no published data with a primary outcome
evaluating spironolactone's effect on the quantity of electrolyte supplementation. We
hypothesize there will be no difference in the amount of electrolyte supplementation between
the two groups.
complication of premature birth and is associated with significant morbidity and mortality.
Bronchopulmonary dysplasia most commonly affects preterm infants who have required prolonged
aggressive mechanical ventilation and/or oxygen supplementation. Risk factors associated
with BPD include degree of prematurity, infection, mechanical ventilation, oxygen
concentration, and nutritional status. Despite significant advances in the care of preterm
infants and improved survival, the incidence of BPD has been fairly static over the past
decade.
Diuretics and fluid restriction are considered a mainstay of therapy in the management of
BPD to combat interstitial alveolar edema. Short courses of furosemide followed by long-term
therapy using a thiazide diuretic with concurrent spironolactone have shown improvement in
pulmonary function and better outcomes. Double-blinded, randomized, placebo-controlled
trials have shown improvement in pulmonary compliance, airway resistance, infants alive at
discharge, and a decrease in fraction of inspired oxygen and need for furosemide boluses.
Spironolactone is a competitive aldosterone receptor antagonist that acts on the distal
convoluted tubule and collecting duct to facilitate sodium excretion while conserving
potassium and hydrogen ions. Since only a minimal amount of sodium filtered by the
glomerulus reaches the distal tubule, spironolactone is considered a weak diuretic.
Spironolactone is primarily used with chlorothiazide for its potassium-sparing effect to
reduce the need for electrolyte supplementation. There has only been one prospective,
randomized, double-blind, placebo-controlled study comparing chlorothiazide with or without
the addition of spironolactone in premature infants with chronic lung disease. This study
demonstrated no difference between the groups in the need for electrolyte supplementation,
electrolyte balance, or pulmonary function. In addition, preterm infants' distal tubules may
respond inadequately to aldosterone; thereby, limiting the role of spironolactone in this
patient population.
In the neonatal population, spironolactone is primarily used in addition with chlorothiazide
for its potassium-sparing effects to reduce the need for electrolyte supplementation.
However, evidence and current practice suggests the majority of patients still receive
electrolyte supplementation. One study evaluated spironolactone's effect on the need for
electrolyte supplementation, but there is no published data with a primary outcome
evaluating spironolactone's effect on the quantity of electrolyte supplementation. We
hypothesize there will be no difference in the amount of electrolyte supplementation between
the two groups.
Inclusion Criteria:
- The attending makes the decision to start enteral chlorothiazide for long-term
diuretic therapy.
- Gestational age < 32 weeks at time of delivery
- If patient is currently receiving furosemide and electrolyte supplements, these must
be discontinued prior to enrollment.
Exclusion Criteria:
- Renal anomaly
- Receiving maintenance IV fluids for more than the previous 48 hours
- Any contraindication to receiving enteral medication
- Serum Na < 132 mEq/L
- Serum K < 3.0 mEq/L
- Serum Cl < 92 mEq/L
- Presence of ostomy of any sort
We found this trial at
1
site
Click here to add this to my saved trials
