The Library
Effect of early Vasopressin vs Norepinephrine on kidney failure in patients with septic shock : the VANISH randomized clinical trial
Tools
Tools
Tools
VANISH Investigators (Including: Gordon, Anthony C., Mason, Alexina J., Thirunavukkarasu, Neeraja, Perkins, Gavin D., Cecconi, Maurizio, Cepkova, Magda, Pogson, David G., Aya, Hollmann D., Anjum, Aisha, Frazier, Gregory J., Santhakumaran, Shalini, Ashby, Deborah and Brett, Stephen J.). (2016) Effect of early Vasopressin vs Norepinephrine on kidney failure in patients with septic shock : the VANISH randomized clinical trial. JAMA: The Journal of the American Medical Association, 316 (5). pp. 509-518. doi:10.1001/jama.2016.10485 ISSN 0098-7484.
|
PDF
WRAP_VANISH JAMA 2016.pdf - Published Version - Requires a PDF viewer. Download (761Kb) | Preview |
|
![[img]](https://wrap.warwick.ac.uk/style/images/fileicons/other.png) |
Office Document (DOCX)
wms_clinical_trials-011119-wrap-change--vanish_esupplement_final_resubmission.docx - Accepted Version Embargoed item. Restricted access to Repository staff only Download (421Kb) |
|
|
Office Document (DOCX)
wms_clinical_trials-011119-wrap-change--vanish_esupplement_final_resubmission.docx - Supplemental Material Embargoed item. Restricted access to Repository staff only Download (421Kb) |
Official URL: http://dx.doi.org/10.1001/jama.2016.10485
Abstract
Importance
Norepinephrine is currently recommended as the first-line vasopressor in septic shock; however, early vasopressin use has been proposed as an alternative.
Objective
To compare the effect of early vasopressin vs norepinephrine on kidney failure in patients with septic shock.
Design, Setting, and Participants
A factorial (2×2), double-blind, randomized clinical trial conducted in 18 general adult intensive care units in the United Kingdom between February 2013 and May 2015, enrolling adult patients who had septic shock requiring vasopressors despite fluid resuscitation within a maximum of 6 hours after the onset of shock.
Interventions
Patients were randomly allocated to vasopressin (titrated up to 0.06 U/min) and hydrocortisone (n = 101), vasopressin and placebo (n = 104), norepinephrine and hydrocortisone (n = 101), or norepinephrine and placebo (n = 103).
Main Outcomes and Measures
The primary outcome was kidney failure–free days during the 28-day period after randomization, measured as (1) the proportion of patients who never developed kidney failure and (2) median number of days alive and free of kidney failure for patients who did not survive, who experienced kidney failure, or both. Rates of renal replacement therapy, mortality, and serious adverse events were secondary outcomes.
Results
A total of 409 patients (median age, 66 years; men, 58.2%) were included in the study, with a median time to study drug administration of 3.5 hours after diagnosis of shock. The number of survivors who never developed kidney failure was 94 of 165 patients (57.0%) in the vasopressin group and 93 of 157 patients (59.2%) in the norepinephrine group (difference, −2.3% [95% CI, −13.0% to 8.5%]). The median number of kidney failure–free days for patients who did not survive, who experienced kidney failure, or both was 9 days (interquartile range [IQR], 1 to –24) in the vasopressin group and 13 days (IQR, 1 to –25) in the norepinephrine group (difference, −4 days [95% CI, −11 to 5]). There was less use of renal replacement therapy in the vasopressin group than in the norepinephrine group (25.4% for vasopressin vs 35.3% for norepinephrine; difference, −9.9% [95% CI, −19.3% to −0.6%]). There was no significant difference in mortality rates between groups. In total, 22 of 205 patients (10.7%) had a serious adverse event in the vasopressin group vs 17 of 204 patients (8.3%) in the norepinephrine group (difference, 2.5% [95% CI, −3.3% to 8.2%]).
Conclusions and Relevance
Among adults with septic shock, the early use of vasopressin compared with norepinephrine did not improve the number of kidney failure–free days. Although these findings do not support the use of vasopressin to replace norepinephrine as initial treatment in this situation, the confidence interval included a potential clinically important benefit for vasopressin, and larger trials may be warranted to assess this further.
| Item Type: | Journal Article | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > RC Internal medicine | |||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
|||||||||
| Library of Congress Subject Headings (LCSH): | Septic shock -- Treatment, Vasopressin, Noradrenaline, Coronary heart disease, Chronic renal failure, Lungs -- Diseases, Obstructive, Liver -- Cirrhosis, Cancer, Immunologic diseases, Diabetes, Clinical trials | |||||||||
| Journal or Publication Title: | JAMA: The Journal of the American Medical Association | |||||||||
| Publisher: | American Medical Association | |||||||||
| ISSN: | 0098-7484 | |||||||||
| Official Date: | 2 August 2016 | |||||||||
| Dates: |
|
|||||||||
| Volume: | 316 | |||||||||
| Number: | 5 | |||||||||
| Page Range: | pp. 509-518 | |||||||||
| DOI: | 10.1001/jama.2016.10485 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Restricted or Subscription Access | |||||||||
| Date of first compliant deposit: | 21 March 2017 | |||||||||
| Date of first compliant Open Access: | 11 June 2017 | |||||||||
| RIOXX Funder/Project Grant: |
|
|||||||||
| Related URLs: |
Request changes or add full text files to a record
Repository staff actions (login required)
 |
View Item |
Downloads
Downloads per month over past year
