Vitamin D3 Supplementation in Critically Ill Patients Undergoing CRRT

Launched by UNIWERSYTECKI SZPITAL KLINICZNY W OPOLU · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial, called the NephroD study, is investigating whether giving critically ill patients in the ICU a higher dose of vitamin D3 can help improve their health. Many patients in the ICU experience a serious deficiency in vitamin D3, which can lead to various complications such as kidney issues and respiratory failure. The study aims to determine if increasing the standard dose of vitamin D3 from 500,000 IU by 50% will better restore vitamin D3 levels in patients who are receiving continuous renal replacement therapy (CRRT) for kidney problems.

To be eligible for this trial, participants must be over 18 years old and have specific health conditions that require CRRT, along with a low level of vitamin D3 in their blood. They should also have a certain score that indicates the severity of their illness. If chosen to participate, patients can expect to receive the higher dose of vitamin D3 and be monitored closely by the medical team. This study hopes to shed light on the importance of vitamin D3 in improving outcomes for critically ill patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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)
• • 2. Sequential Organ Failure Assessment (SOFA) score of minimum 5 points at enrolment
• • 3. Age of \>18 years
• • 4. Plasma 25(OH)D3 levels ≤12.5 ng/ml as measured by the local laboratory of a participating hospital
• • 5. Properly managed enteral nutrition regardless of dosing
• Exclusion Criteria:
• • 1. Acute or advanced chronic liver failure (estimated on the basis of the clinical picture and biochemical markers: plasma bilirubin, plasma AST and ALT, high plasma AST/ALT ratio, glycaemia, INR)
• • 2. Hypercalcaemia (total calcium concentration \>11 mg/dl)
• • 3. Any parathyroid disorder
• • 4. End stage renal disease according to the KDIGO classification
• • 5. Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide removal (ECCO2R)
• • 6. Patients who, in the opinion of the investigator, are not expected to survive 72 hours since enrolment
• • 7. A history of nephrolithiasis or de novo nephrolithiasis
• • 8. Patient qualified to a protocol for the avoidance of futile therapy
• • 9. Pregnancy
• • 10. Sarcoidosis
• • 11. Risk of impaired intestinal absorption caused by the critical illness, associated with impaired peristalsis and delayed gastric emptying, constipation, diarrhoea, shock-induced intestinal hypoperfusion, hyperhydration with resulting intestinal oedema following fluid resuscitation, intestinal flora disorders.

Trial Officials