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Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

Motivation:

In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.

Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.

LHA ID: 7Q0CV4F4EM-5

Projects: SepNet - German Competence Network Sepsis

Investigation position:

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Creators and Submitter

Creator

Markus Löffler

Submitter

Christoph Beger

Activity

Views: 2865

Created: 6th May 2019 at 06:37

Last updated: 4th Jun 2020 at 08:34

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Studies (1)
Resources (2)
Publications (2)
Data files (20)
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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

VISEP

SepNet - German Competence Network Sepsis

All creators

Markus Löffler

Baseline Data and Endpoints for VISEP

Submitter: René Hänsel

Investigation: Efficacy of Volume Substitution and Insulin The...

Resources: VISEP metadata, VISEP trial data

Study type: Not specified

Snapshots: No snapshots

Created: 20th May 2019 at 13:11, Last updated: 20th May 2019 at 13:11

VISEP trial data

SepNet - German Competence Network Sepsis

All creators

Markus Löffler

The role of intensive insulin therapy in patients with severe sepsis is uncertain. Fluid resuscitation improves survival among patients with septic shock, but evidence is lacking to support the choice of either crystalloids or colloids. We compared intensive insulin therapy with conventional insulin therapy and HES with Ringer’s lactate.

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: Efficacy of Volume Substitution and Insulin The...

Study: VISEP

Human Diseases: disease by infectious agent

Data files: VISEP Endpoint, VISEP Endpoint-ODM, VISEP Endpoint-SPSS, VISEP V-PAT, VISEP V-PAT-ODM, VISEP V-PAT-SPSS, VISEP V-VERL-join, VISEP V-VERL-join-ODM, VISEP V-VERL-join-SPSS, VISEP haemo_join, VISEP haemo_join-ODM, VISEP haemo_join-SPSS

Snapshots: No snapshots

Created: 20th May 2019 at 13:16, Last updated: 30th Aug 2019 at 13:30

VISEP metadata

SepNet - German Competence Network Sepsis

All creators

Markus Löffler

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: Efficacy of Volume Substitution and Insulin The...

Study: VISEP

Human Diseases: disease by infectious agent

Data files: VISEP Endpoint Metadata, VISEP Endpoint Metadata-ODM, VISEP V-PAT Metadata, VISEP V-PAT Metadata-ODM, VISEP V-VERL-join Metadata, VISEP V-VERL-join Metadata-ODM, VISEP haemo_join Metadata, VISEP haemo_join Metadata-ODM

Snapshots: No snapshots

Created: 20th May 2019 at 13:15, Last updated: 30th Aug 2019 at 13:30

Enteral nutrition is associated with improved outcome in patients with severe sepsis. A secondary analysis of the VISEP trial.

SepNet - German Competence Network Sepsis

All authors

Markus Löffler

Konrad Reinhart

Abstract (Expand)

INTRODUCTION: The optimal nutritional strategy remains controversial, particularly in severely septic patients. Our aim was to analyze the effect of three nutritional strategies--enteral (EN), parenteral … (PN), and combined nutrition (EN+PN)--on the outcome of patients with severe sepsis or septic shock. PATIENTS AND METHODS: This secondary analysis of the prospective, randomized-controlled, multicenter "Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis (VISEP)" trial only included patients with a length of stay in the intensive care unit (ICU) of more than 7 days. Besides patient characteristics, data on nutrition therapy were collected daily for up to 21 days. Morbidity as measured by the mean Sequential Organ Failure Assessment (SOFA) score, incidence of secondary infections, renal replacement therapy, ventilator-free days and severe hypoglycemia, length of ICU stay, and mortality at 90 days were compared between the three nutritional strategies. RESULTS: In all, 353 patients were included in the analysis with the majority (68.5 %) receiving EN+PN, 24.4 % receiving EN, and only 7.1 % receiving PN. Median caloric intake was 918 kcal/day (EN), 1,210 kcal/day (PN), and 1,343 kcal/day (EN+PN; p < 0.001). In the latter group, calories were predominantly administered via the parenteral route within the first week. The rate of death at 90 days was lower with EN than with EN+PN (26.7 % vs. 41.3 %, p = 0.048), as was the rate of secondary infections, renal replacement therapy, and duration of mechanical ventilation. In the adjusted Cox regression analysis, the effect on mortality [hazard ratio (HR)= 1.86, 95 % confidence interval (CI): 1.16-2.98, p = 0.010] and the rate of secondary infections (HR= 1.89, 95 % CI: 1.27-2.81, p = 0.002) remained different between EN and EN+PN. CONCLUSION: In patients with severe sepsis or septic shock and prolonged ICU stay, EN alone was associated with improved clinical outcome compared to EN+PN. This hypothesis-generating result has to be confirmed by a randomized-controlled trial in this specific patient population.

Authors: G. Elke, E. Kuhnt, M. Ragaller, D. Schadler, I. Frerichs, F. M. Brunkhorst, M. Loffler, K. Reinhart, N. Weiler

Date Published: 5th Mar 2013

Publication Type: Not specified

Human Diseases: disease by infectious agent

PubMed ID: 23455443

Citation: Med Klin Intensivmed Notfmed. 2013 Apr;108(3):223-33. doi: 10.1007/s00063-013-0224-4. Epub 2013 Mar 3.

Created: 6th May 2019 at 06:38, Last updated: 7th Dec 2021 at 17:58

Intensive insulin therapy and pentastarch resuscitation in severe sepsis.

SepNet - German Competence Network Sepsis

All authors

Markus Löffler

Christoph Engel

Abstract (Expand)

BACKGROUND: The role of intensive insulin therapy in patients with severe sepsis is uncertain. Fluid resuscitation improves survival among patients with septic shock, but evidence is lacking to support … the choice of either crystalloids or colloids. METHODS: In a multicenter, two-by-two factorial trial, we randomly assigned patients with severe sepsis to receive either intensive insulin therapy to maintain euglycemia or conventional insulin therapy and either 10% pentastarch, a low-molecular-weight hydroxyethyl starch (HES 200/0.5), or modified Ringer's lactate for fluid resuscitation. The rate of death at 28 days and the mean score for organ failure were coprimary end points. RESULTS: The trial was stopped early for safety reasons. Among 537 patients who could be evaluated, the mean morning blood glucose level was lower in the intensive-therapy group (112 mg per deciliter [6.2 mmol per liter]) than in the conventional-therapy group (151 mg per deciliter [8.4 mmol per liter], P<0.001). However, at 28 days, there was no significant difference between the two groups in the rate of death or the mean score for organ failure. The rate of severe hypoglycemia (glucose level, < or = 40 mg per deciliter [2.2 mmol per liter]) was higher in the intensive-therapy group than in the conventional-therapy group (17.0% vs. 4.1%, P<0.001), as was the rate of serious adverse events (10.9% vs. 5.2%, P=0.01). HES therapy was associated with higher rates of acute renal failure and renal-replacement therapy than was Ringer's lactate. CONCLUSIONS: The use of intensive insulin therapy placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia. As used in this study, HES was harmful, and its toxicity increased with accumulating doses. (ClinicalTrials.gov number, NCT00135473.)

Authors: F. M. Brunkhorst, C. Engel, F. Bloos, A. Meier-Hellmann, M. Ragaller, N. Weiler, O. Moerer, M. Gruendling, M. Oppert, S. Grond, D. Olthoff, U. Jaschinski, S. John, R. Rossaint, T. Welte, M. Schaefer, P. Kern, E. Kuhnt, M. Kiehntopf, C. Hartog, C. Natanson, M. Loeffler, K. Reinhart