Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Presence of the following indications for initiation of CRRT with CVVHDF or CVVHF (acc. to KDIGO, Clinical Practice Guideline for Acute Kidney Injury):

‣ replacement of kidney function in acute kidney injury

⁃ hyperkalaemia

⁃ metabolic acidosis

⁃ pulmonary oedema

⁃ uraemic complications (bleeding disorder, pericarditis)

⁃ hypervolaemia

⁃ support of renal function (volume control, regulation of acid-base and electrolyte status)

• Sequential Organ Failure Assessment (SOFA) score of minimum 5 points at enrolment

• Age of \>18 years

• Plasma 25(OH)D3 levels ≤12.5 ng/ml as measured by the local laboratory of a participating hospital

• Properly managed enteral nutrition regardless of dosing

Locations
Other Locations
Poland
5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
RECRUITING
Krakow
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny w Opolu
RECRUITING
Opole
Samodzielny Publiczny Szpital Kliniczny nr 1 Śląski Uniwersytet Medyczny w Katowicach
RECRUITING
Zabrze
Contact Information
Primary
Tomasz Czarnik, MD, PhD
tczarnik@mac.com
0048669906333
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 138
Treatments
Experimental: Interventional Arm
a single administration of 750,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels ≤12.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF
Active_comparator: Control Arm
a single administration of 500,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels ≤12.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF
Related Therapeutic Areas
Sponsors
Leads: Uniwersytecki Szpital Kliniczny w Opolu

This content was sourced from clinicaltrials.gov