Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial.
Lederer DJ, Philip N, Rybak D, et al.PLoS ONE. 2014 ;9(8):e103908
Aims
To evaluate the safety and efficacy of intravenous immunoglobulin (IVIG) therapy in patients with hypogammaglobulinemia (HGG) following lung transplantation.
Interventions
Participants were administered with human IVIG or placebo 0.1% albumin.
Participants
11 adult lung transplant recipients at least three months post-transplant with HGG.
Outcomes
The primary outcome was the number of bacterial infections during the treatment period. The secondary outcomes included viral, fungal and all non-bacterial infections, hospital admissions, antimicrobial use, serious bacterial infections, trough Immunoglobulin G levels, acute rejection, spirometry and mortality in each period.
Follow-up
3 months.
CET Conclusions
This small study investigates the use of intravenous immunoglobulin (IVIg) in lung transplant recipients with hypogammaglobulinaemia. The authors set out to see if reconstituting the circulating IvIG level would reduce the risk of infection, but did not see any difference in bacterial, fungal or viral infection rates. Despite the use of a power calculation and a cross-over design to attempt to increase statistical power, the study remains underpowered. Only 11 patients were recruited, and one was lost to follow-up. With the rate of bacterial infection being lower than anticipated, the confidence interval for the primary outcome (odds ratio for bacterial infection) is wide, ranging from 0.4 to 27.6. Either of these values would be of clinical significance if true, meaning that no firm conclusions can be drawn from this study.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov – NCT00115778