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HYPRESS

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LHA ID: 7WGHQ13JUC-6

Projects: SepNet - German Competence Network Sepsis

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Christoph Engel

Submitter

Christoph Beger

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Created: 20th May 2019 at 13:38

Last updated: 20th May 2019 at 13:38

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SepNet - German Competence Network Sepsis

As an interdisciplinary network of scientists, the SepNet study group deals with the topics of severe sepsis and septic shock. The aim of the network is to create the prerequisites for better clinical and experimental research into sepsis and thus to develop efficient treatment approaches.

Programme: LIFE Management Cluster

Public web page: https://www.sepsis-stiftung.eu/sepnet/

Start date: 1st Jan 2003

Organisms: Homo sapiens

Human Diseases: disease by infectious agent

HYPRESS

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

Baseline Data and Endpoints for HYPRESS

Submitter: Christoph Beger

Investigation: HYPRESS

Resources: HYPRESS Trial Data, HYPRESS Trial Metadata

Study type: Not specified

Snapshots: No snapshots

Created: 20th May 2019 at 13:39, Last updated: 20th May 2019 at 13:51

HYPRESS Trial Data

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

Adjunctive hydrocortisone (HC) therapy is suggested by the Surviving Sepsis Campaign in refractory septic shock only. The case for septic patients without shock remains controversial. We investigated the efficacy of HC in patients with severe sepsis without shock

Restricted Trial Data

Submitter: Christoph Beger

Resource type: Result Dataset of Clinical Study

Technology type: Technology Type

Investigation: HYPRESS

Study: HYPRESS

Human Diseases: disease by infectious agent

Data files: HYPRESS Trial Data (Excel), HYPRESS Trial Data (SPSS), Hypress Trial Data (ODM)

Snapshots: No snapshots

Created: 20th May 2019 at 13:42, Last updated: 20th May 2019 at 13:59

HYPRESS Trial Metadata

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

No description specified

Submitter: Christoph Beger

Resource type: Result Dataset of Clinical Study

Technology type: Technology Type

Investigation: HYPRESS

Study: HYPRESS

Human Diseases: disease by infectious agent

Data files: HYPRESS Trial Metadata (Excel), HYPRESS Trial Metadata (ODM)

Snapshots: No snapshots

Created: 20th May 2019 at 13:41, Last updated: 20th May 2019 at 13:59

Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial.

SepNet - German Competence Network Sepsis

(Show All)

All authors

Christoph Engel

Markus Löffler

Konrad Reinhart

Abstract (Expand)

Importance: Adjunctive hydrocortisone therapy is suggested by the Surviving Sepsis Campaign in refractory septic shock only. The efficacy of hydrocortisone in patients with severe sepsis without shock … remains controversial. Objective: To determine whether hydrocortisone therapy in patients with severe sepsis prevents the development of septic shock. Design, Setting, and Participants: Double-blind, randomized clinical trial conducted from January 13, 2009, to August 27, 2013, with a follow-up of 180 days until February 23, 2014. The trial was performed in 34 intermediate or intensive care units of university and community hospitals in Germany, and it included 380 adult patients with severe sepsis who were not in septic shock. Interventions: Patients were randomly allocated 1:1 either to receive a continuous infusion of 200 mg of hydrocortisone for 5 days followed by dose tapering until day 11 (n = 190) or to receive placebo (n = 190). Main Outcomes and Measures: The primary outcome was development of septic shock within 14 days. Secondary outcomes were time until septic shock, mortality in the intensive care unit or hospital, survival up to 180 days, and assessment of secondary infections, weaning failure, muscle weakness, and hyperglycemia (blood glucose level >150 mg/dL [to convert to millimoles per liter, multiply by 0.0555]). Results: The intention-to-treat population consisted of 353 patients (64.9% male; mean [SD] age, 65.0 [14.4] years). Septic shock occurred in 36 of 170 patients (21.2%) in the hydrocortisone group and 39 of 170 patients (22.9%) in the placebo group (difference, -1.8%; 95% CI, -10.7% to 7.2%; P = .70). No significant differences were observed between the hydrocortisone and placebo groups for time until septic shock; mortality in the intensive care unit or in the hospital; or mortality at 28 days (15 of 171 patients [8.8%] vs 14 of 170 patients [8.2%], respectively; difference, 0.5%; 95% CI, -5.6% to 6.7%; P = .86), 90 days (34 of 171 patients [19.9%] vs 28 of 168 patients [16.7%]; difference, 3.2%; 95% CI, -5.1% to 11.4%; P = .44), and 180 days (45 of 168 patients [26.8%] vs 37 of 167 patients [22.2%], respectively; difference, 4.6%; 95% CI, -4.6% to 13.7%; P = .32). In the hydrocortisone vs placebo groups, 21.5% vs 16.9% had secondary infections, 8.6% vs 8.5% had weaning failure, 30.7% vs 23.8% had muscle weakness, and 90.9% vs 81.5% had hyperglycemia. Conclusions and Relevance: Among adults with severe sepsis not in septic shock, use of hydrocortisone compared with placebo did not reduce the risk of septic shock within 14 days. These findings do not support the use of hydrocortisone in these patients. Trial Registration: clinicaltrials.gov Identifier: NCT00670254.

Authors: D. Keh, E. Trips, G. Marx, S. P. Wirtz, E. Abduljawwad, S. Bercker, H. Bogatsch, J. Briegel, C. Engel, H. Gerlach, A. Goldmann, S. O. Kuhn, L. Huter, A. Meier-Hellmann, A. Nierhaus, S. Kluge, J. Lehmke, M. Loeffler, M. Oppert, K. Resener, D. Schadler, T. Schuerholz, P. Simon, N. Weiler, A. Weyland, K. Reinhart, F. M. Brunkhorst