| Title |
Design and conduct of the activated protein C and corticosteroids for human septic shock (APROCCHSS) trial
|
|---|---|
| Published in |
Annals of Intensive Care, May 2016
|
| DOI | 10.1186/s13613-016-0147-3 |
| Pubmed ID | |
| Authors |
Djillali Annane, Christian Brun Buisson, Alain Cariou, Claude Martin, Benoit Misset, Alain Renault, Blandine Lehmann, Valérie Millul, Virginie Maxime, Eric Bellissant |
| Abstract |
We aimed at assessing the benefit-to-risk ratio of activated protein C (drotrecogin-alfa activated, DAA) and corticosteroids, given alone or in combination, in patients with septic shock. We implemented an investigator-led, publicly funded, multicenter, randomized according to a 2 × 2 factorial design, placebo-controlled, double-blind trial in four parallel groups in which adults with persistent septic shock and no contraindication to DAA were assigned to either DAA alone (24 mg/kg/h for 96 h), or hydrocortisone (50 mg intravenous bolus q6 for 7 days) and fludrocortisone (50 µg once daily through the nasogastric tube for 7 days) alone, or their respective combinations, or their respective placebos. Primary endpoint was 90-day mortality rate. Follow-up duration was 6 months. Statistical analysis was planned to be performed in intent-to-treat once after all participants completed 180-day follow-up and according to the 2 × 2 factorial design. The first patient was recruited in September 2008. The trial was suspended on October 25, 2011, owing to the withdrawal from the market of DAA. At this time, 411 patients had been enrolled. On May 17, 2012, the continuation of the trial on two parallel groups was approved by all legal authorities with the aim of investigating the benefit-to-risk ratio of corticosteroids. On June 30, 2014, the trial was suspended again by the study sponsor upon request of the independent data and safety monitoring board. Recruitment restarted on October 7, 2014, after any safety concern was ruled out. Finally, the trial was completed on June 23, 2015, with the recruitment of 1241 patients. This report details the design, statistical plan and conduct of a randomized controlled trial of hydrocortisone and fludrocortisone in septic shock. Trial registration The trial was registered at ClinicalTrials.gov under NCT00625209. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| France | 1 | 50% |
| Spain | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 48 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 48 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 8 | 17% |
| Student > Master | 7 | 15% |
| Student > Postgraduate | 5 | 10% |
| Student > Bachelor | 4 | 8% |
| Student > Doctoral Student | 3 | 6% |
| Other | 9 | 19% |
| Unknown | 12 | 25% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 22 | 46% |
| Nursing and Health Professions | 4 | 8% |
| Agricultural and Biological Sciences | 3 | 6% |
| Biochemistry, Genetics and Molecular Biology | 2 | 4% |
| Immunology and Microbiology | 2 | 4% |
| Other | 5 | 10% |
| Unknown | 10 | 21% |
Attention Score in Context
This research output has an Altmetric Attention Score of 8. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 21 February 2020.
All research outputs
#3,995,547
of 22,869,263 outputs
Outputs from Annals of Intensive Care
#455
of 1,044 outputs
Outputs of similar age
#62,367
of 298,725 outputs
Outputs of similar age from Annals of Intensive Care
#6
of 28 outputs
Altmetric has tracked 22,869,263 research outputs across all sources so far. Compared to these this one has done well and is in the 82nd percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,044 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 16.8. This one has gotten more attention than average, scoring higher than 55% of its peers.
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We're also able to compare this research output to 28 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 78% of its contemporaries.