• Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a highly collegial group that is dedicated to the pursuit of excellence and advancement of critical care research in Canada.
  • Canadian Critical Care Trials Group
    The CCCTG has are more than 30 research programs underway and over 100 peer-reviewed publications to its credit, with direct impact on clinical practice in critical care.
  • Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a national organization of more than 300 individuals with research interests in the management of the critically ill patient.
  • Canadian Critical Care Trials Group
    Endorsement by the CCCTG communicates our full commitment to ensure that the work is undertaken in a rigorous and ethical manner, and communicated in a timely and effective way.
Programs

Principal Investigator(s)

Dayre McNally

Coordinator(s)

Katie O’Hearn

Status

Not Yet Recruiting

HICCUPS - Hypovitaminosis-D In Critically ill Children: Understanding Pathways and Solutions (1)

Background: Vitamin D is recognized as a pleiotropic hormone important for the functioning of multiple organ systems central to critical illness pathophysiology. This has led to questions about whether vitamin D deficiency might represent a modifiable risk factor in the prevention or recovery from critical illness. Pediatric observational studies have documented an association between blood 25 hydroxyvitamin D and organ dysfunction, health resource utilization, and mortality in PICU and post-surgical congenital heart diseased populations.

Program Research Hypothesis: Optimization of vitamin D status reduces critical illness severity and improves outcomes

Program Design:
Aim 1 (Prevention/Congenital Heart Disease) Phases of Research:
1. Observational study evaluating the impact of cardiac surgery on vitamin D deficiency in children with congenital heart disease (CHD)
2. Pilot RCT evaluating high-dose vitamin D supplementation in children with CHD (recruiting)
3. Phase II, multi-centre RCT comparing high-dose versus usual care vitamin D dosing
4. Multi-centre RCT comparing clinical outcomes with high-dose versus usual care vitamin D dosing


Aim 2 (Rapid Restoration Dose) Phases of Research:
1. A multi-centre epidemiologic study on vitamin D deficiency among critically ill children
2. A systematic review on the efficacy and safety of vitamin D dosing regimens that exceed the daily tolerable intake level
3. Phase II RCT to determine whether a rapid restoration dose of vitamin D can safely restore normal vitamin D levels in critically ill children
4. Multi-centre RCT comparing the clinical outcomes of rapid restoration versus usual care vitamin D dosing

Clinical trials.gov links to study NCT02452762 and NCT01838447

References
  1. McNally JD, Amrein K, O’Hearn K, Fergusson D, Geier P, Henderson M, Khamessan A, Lawson M, McIntyre L, Redpath S, Weiler H, Menon K. “Study Protocol for a Phase II Dose Evaluation Randomized Controlled Trial of Cholecalciferol in Critically Ill Children with Vitamin D Deficiency (VITDAL-PICU). Pilot and Feasibility Studies. 2017; 3: 70. Doi: 101186/s40814-017-0214-z (PMID: 29234503).
  2. McNally JD, Nama N, O’Hearn K, Sampson M, Amrein K, Iliriani K, McIntyre L, Fergusson D, Menon K. “Vitamin D deficiency in critically ill children: A systematic review and meta-analysis”. Critical Care. 2017; 21(1):287. Doi 10.1186/s13054-017-1875-y (PMID: 29169388).
  3. McNally JD, O’Hearn K, Lawson ML, Maharajh G, Geier P, Weiler H, Redpath S, McIntyre L, Fergusson D, Menon K (on behalf of the CCCTG). “Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial.” Trials  2015; 16(1)402. (PMID: 26353829)
  4. McNally JD, Iliriani K, Pojsupap S, Sampson M, O’Hearn K, McIntyre L, Fergusson D, Menon K. “Rapid normalization of vitamin D levels: A meta-analysis”. Pediatrics. 2015; 135(1): e152-e166. (PMID: 25511115) *Impact Factor: 5.5
  5. McNally JD, Menon K, Chakraborty P, Fisher L, Williams KA, Al-Dirbashi OY, Girolamo T, Maharajh G, Doherty DR. "Impact of Anesthesia and Surgery for Congenital Heart Disease on the Vitamin D Status of Infants and Children: A Prospective Longitudinal Study" Anesthesiology. 2013; 14(5):462-6. (PMID: 23470437) *Impact Factor: 5.2
  6. McNally JD, Doherty DR , Lawson ML , Al-Dirbashi OY , Chakraborty P , Ramsay T , Menon K, "The relationship between vitamin d status and adrenal insufficiency in critically ill children", JCEM, 2013; 98(5):E877-81. (PMID: 23547046) *Impact Factor: 6.2.
  7. McNally JD, Menon K, Chakraborty P, Fisher L, Williams KA, Al-Dirbashi OY, Doherty DR, “The association of vitamin D status  with pediatric critical illness”, Pediatrics. 2012; 130(3)429-36. (PMID: 22869837) *Impact Factor: 5.5

Co-Investigators

Aim 1: Prevention/Congenital Heart Disease Research Program:
Dayre McNally, Kusum Menon, Katie O’Hearn, Jane Lougheed, Dean Fergusson4, Dermot Doherty Gyaandeo Maharajh, Hope Weiler7, Glenville Jones Ali Khamessan; Stephanie Redpath; Pavel Geier; Lauralyn McIntyre; Margaret Lawson

Aim 2: Rapid Restoration Dose Research Program:
Kusum Menon, Dean Fergusson, Lauralyn McIntyre, Patricia Fontela (Montreal), Anna Gunz (London), Karin Amrein (Austria), Dean Fergusson, Margaret Lawson, Pavel Geier, Stephanie Redpath, Raul Bustos (Chile), Katie O’Hearn

Participating Centers

Phase II Rapid Restoration Pilot Dose Evaluation RCT:
Children’s Hospital of Eastern Ontario (Ottawa, Canada)
London Health Sciences Centre (London, Canada)
Medical University of Graz (Graz, Austria)
Hospital Guillermo Grant Benavente (Concepcion, Chile)

Rapid Restoration Multi-centre RCT
to be confirmed