- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02869919
Vitamin D in Critically Ill Patients With Acute Kidney Injury (VID-AKI)
Vitamin D Levels in Critically Ill Patients With Acute Kidney Injury
Studieoversigt
Detaljeret beskrivelse
Vitamin D has an important role in calcium homeostasis and the regulation of bone metabolism. It also appears to play a role in various infectious, immunologic, neurologic, cardiovascular and respiratory disorders. Both, biological and observational studies have identified vitamin D deficiency as a risk factor for adverse outcomes during critical illness. However, administration of high dose vitamin D to a general population of critically ill patients with vitamin D deficiency did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) where hospital mortality was significantly lower in patients treated with Vitamin D.
Vitamin D Metabolism The majority of vitamin D is produced through the direct action of sunlight on 7-dehydrocholesterol in the skin. The inert Vitamin D3 produced in this manner, together with Vitamin D2 or D3 from dietary sources, require hydroxylation in the liver to 25-hydroxyvitamin D [25(OH)D] which is the main circulating form. Conversion of this still inactive substance to the active form, 1,25-dihydroxyvitamin D [1,25(OH)2D], by the enzyme 1α-hydroxylase occurs primarily, but not exclusively, in the proximal renal tubules. Circulatory phosphorous, parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) play an important regulatory role in this process. FGF23 is a bone derived hormone that inhibits renal tubular absorption of phosphate and reduces circulating 1,25(OH)2D. PTH is a hormone secreted by the parathyroid glands in response to hypocalcaemia. It acts to increase the concentration of calcium through several pathways one of which is the upregulation of 1α-hydroxylase, the enzyme responsible for converting 25(OH)D to 1,25(OH)2D.
The majority of both 25(OH)D and 1,25(OH)2D is bound to Vitamin D Binding Protein (VDBP) in circulation. The nuclear Vitamin D Receptors (VDR) which regulate the transcription and expression of Vitamin D targeted genes are only activated by unbound 1,25(OH)2D, which is less than 1% of total circulating Vitamin D.
Vitamin D in chronic kidney disease In patients with chronic kidney disease (CKD) on chronic dialysis, Vitamin D deficiency is common (>80%), and the supplementation with active Vitamin D preparations is strongly recommended to prevent or ameliorate the effects of hyperparathyroid high-turnover bone disease and to reduce the cardiovascular risk.
Vitamin D in general ICU patients ICUs worldwide have reported Vitamin D deficiency ranging from 60-100%. A randomized controlled trial (RCT) in a general population of critically ill patients with vitamin D deficiency showed that administration of high dose vitamin D did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) in whom hospital mortality was significantly lower in patients treated with Vitamin D. Another RCT investigated the role of 2 different doses of cholecalciferol in 50 critically ill adults with the systemic inflammatory response syndrome. The study showed that prior to randomization 56% of patients were classified as Vitamin D deficient. By day 7 after randomization, Vitamin D levels normalized in >60% of patients and PTH levels decreased over the study period.
Vitamin D and AKI AKI is an abrupt deterioration in kidney function which develops over hours or days for a variety of reasons and can range from mild impairment to acute kidney failure. It affects >50% of critically ill patients worldwide and is independently associated with an increased risk of complications, a longer stay in hospital and high risk of dying. AKI survivors have an increased risk of CKD and premature mortality. A recent study also confirmed a significantly increased risk of bone fractures in patients who survived an episode of AKI requiring renal replacement therapy (RRT).
The causal mechanisms behind the morbidity and mortality associated with AKI are still not fully understood but Vitamin D may play an important role.
The hypothesis of this study is that critically ill patients with AKI have significantly lower Vitamin D levels than critically ill patients without AKI.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Greater London
-
London, Greater London, Det Forenede Kongerige, SE1 7EH
- Guy's & St Thomas Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
age >18 years presence of organ failure
Exclusion Criteria:
Chronic kidney disease stage 3b-5 Renal Transplant Vitamin D deficiency Vitamin D supplementation Hyperparathyroidism Treatment with total parenteral nutrition Life expectancy <48 hours Patients with haemoglobin <70g/L
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Patients with AKI
critically ill patients with acute kidney injury
|
Vitamin D levels
|
Patients without AKI
critically ill patients without acute kidney injury
|
Vitamin D levels
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Vitamin D levels
Tidsramme: up to 28 days
|
up to 28 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
PTH levels
Tidsramme: up to 28 days
|
up to 28 days
|
FGF23 levels
Tidsramme: up to 28 days
|
up to 28 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Marlies Ostermann, PhD, Guy's & St Thomas Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRAS 196968
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Akut nyreskade
-
Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and...AfsluttetModerat til alvorligt traume, som defineret af en | Injury Severity Score (ISS) > 12 point var inkluderet i undersøgelsen.Spanien
Kliniske forsøg med AKI
-
Selayang HospitalAfsluttetAkut nyreskade | Akut nyresvigt | Nyresvigt, akut | Hospitalserhvervet tilstandMalaysia
-
Mayo ClinicAfsluttetAkut nyreskadeForenede Stater
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonAktiv, ikke rekrutterende
-
Policlinico HospitalIkke rekrutterer endnuAkut nyreskade | ARDS, menneske
-
Unity Health TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Mount...UkendtNephrologist opfølgning versus sædvanlig pleje efter en akut nyreskade hospitalsindlæggelse (FUSION)Kronisk nyresygdom | Akut nyreskadeCanada
-
XinLing LiangAfsluttet
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalAfsluttetAkut nyreskade | Væskeoverbelastning | Perioperative/postoperative komplikationer | VæsketabKalkun
-
University of ChicagoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereRekrutteringBiomarkører | Akut nyreskadeForenede Stater
-
Vanderbilt University Medical CenterAfsluttetAkut nyreskade | Nyre sygdom | NyreskadeForenede Stater