Patients hospitalized in intensive care units (ICU) are particularly susceptible to vitamin D3 deficiencies. This can be due to the severity of their underlying disease, the type of treatment they are on, malnutrition before and inadequate nutrition during the hospitalisation preceding ICU admission, as well as advanced age. It has also been established that plasma levels of 25(OH)D3 tend to systematically decrease during ICU treatment. Therapeutic interventions administered in ICU settings such as fluid resuscitation or extracorporeal therapies can cause additional vitamin D3 deficiencies. The incidence of deficiency in critically ill patients can reach up to 90%, and even 30% of ICU patients can have undetectable plasma levels. It is impossible to replenish vitamin D3 levels in critically ill patients with traditional enteral and parenteral nutrition treatment regimens, because nutritional products contain too little of the vitamin. Vitamin D3 deficiency in critically ill patients has been associated with acute kidney injury, acute respiratory failure, sepsis, septic shock and increased all-cause ICU mortality. Despite that, assessment of plasma 25(OH)D3 levels is not a routine practice in ICUs. In view of the prevalence of vitamin D3 deficiencies in ICU patients, rapid replenishment of this deficiency with an increased supplementation dose should be considered as a potential means to improve prognosis in this patient population. The current standard therapy is the administration of 500,000 IU of vitamin D3 via the enteral route in ICU patients with severe deficiency (recommended by ESPEN). The NephroD study is meant to help answer the question whether increasing the standard ICU supplementation dose of vitamin D3 by 50% will ensure a more effective replenishment of this vitamin in critically ill patients undergoing CRRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
138
a single administration of 750,000 IU of vitamin D3
a single administration of 500,000 IU of vitamin D3
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, Poland
RECRUITING5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Krakow, Poland
RECRUITINGSamodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland
RECRUITINGSamodzielny Publiczny Szpital Kliniczny nr 1 Śląski Uniwersytet Medyczny w Katowicach
Zabrze, Poland
RECRUITINGSupplementation
To evaluate and compare the effects of two different supplementation doses of vitamin D3 (25(OH)D3) - 500,000 IU or 750,000 IU administered as one enteral dose - on plasma levels of 25(OH)D3 in ICU patients undergoing continuous renal replacement therapy and diagnosed with severe vitamin D3 deficiency
Time frame: 7 days
Mortality
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on mortality in ICU patients undergoing continuous renal replacement therapy
Time frame: 90 days
ICU treatment duration
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on ICU treatment duration in patients undergoing continuous renal replacement therapy
Time frame: 90 days
SOFA
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on Sequential Organ Failure Assessment (SOFA) scores in ICU patients undergoing continuous renal replacement therapy
Time frame: 90 days
Catecholamines
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on the duration of catecholamine administration in ICU patients undergoing continuous renal replacement therapy
Time frame: 90 days
CRRT
To evaluate the relationship between the length of CRRT use in hours from the time of study drug administration to the beginning of visit 4 and serum vitamin D3 levels in both study arms
Time frame: 7 days
GRV
To assess the relationship between total gastric residual volume (GRV) in millilitres from the time of study drug administration to the date of the beginning of visit 3 and serum vitamin D3 levels in both study arms
Time frame: 7 days
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