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Scandinavian Starch for Severe Sepsis/Septic Shock Trial

2014-08-27 03:19:56 | BioPortfolio

Summary

- By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.

- High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.

- Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.

- HES 130/0.4 is largely unstudied in ICU patients.

- This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.

- The trial will provide important data to all clinicians who resuscitate septic patients.

Description

Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown.

Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ICU patients are currently unknown. The proposed Scandinavian multicentre study will be conducted to assess if HES 130 contributes to acute kidney failure in patients with severe sepsis. As HES 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Severe Sepsis

Intervention

6% Hydroxyethyl starch 130/0.4, Ringers acetate

Location

Rigshospitalet
Copenhagen
Denmark

Status

Recruiting

Source

Scandinavian Critical Care Trials Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:56-0400

Clinical Trials [1018 Associated Clinical Trials listed on BioPortfolio]

Crystalloid Versus Hydroxyethyl Starch Trials

The aim of this study is to determine whether patients in the Intensive Care Unit who receive fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline (...

Trial of 6% HES130/0.4

The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy...

Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)

The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is...

HyperHAES Versus Placebo – Effect on Intracranial Pressure in SAH Patients

The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a pla...

Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well est...

PubMed Articles [6101 Associated PubMed Articles listed on BioPortfolio]

Resuscitation with centhaquin and 6% hydroxyethyl starch 130/0.4 improves survival in a swine model of hemorrhagic shock: a randomized experimental study.

To investigate the effects of the combination of centhaquin and 6% hydroxyethyl starch 130/0.4 (HES 130/0.4) in a swine model of hemorrhagic shock.

Prediction of bleeding by thromboelastography in ICU patients with haematological malignancy and severe sepsis.

: ICU patients with haematological malignancy have an increased risk of bleeding. Recently, global haemostatic methods such as thromboelastography (TEG) have gained impact in evaluating coagulation. T...

Concentration and value of endocan on outcome in adult patients after severe sepsis.

Endothelial dysfunction plays a central role in severe sepsis. Endocan is constitutively expressed in human endothelial cells when sepsis occurs. We tested the hypothesis that endocan concentrations a...

Hypertonic saline-hydroxyethyl starch solution attenuates fluid accumulation in cardiac surgery patients: a randomized controlled double-blind trial.

Significant fluid retention is common after cardiac surgery with the use of cardiopulmonary bypass (CPB). The aim of the study was to evaluate the effects of hypertonic saline-hydroxyethyl starch (HS-...

The Use of Hydroxyethyl Starch 130/0.4 in Surgery Patients.

Medical and Biotech [MESH] Definitions

Starches that have been chemically modified so that a percentage of OH groups are substituted with 2-hydroxyethyl ether groups.

Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.

Acute neurological dysfunction during severe SEPSIS in the absence of direct brain infection characterized by systemic inflammation and BLOOD BRAIN BARRIER perturbation.

An anti-androgen that, in the form of its acetate (CYPROTERONE ACETATE), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females.

The presence of fungi circulating in the blood. Opportunistic fungal sepsis is seen most often in immunosuppressed patients with severe neutropenia or in postoperative patients with intravenous catheters and usually follows prolonged antibiotic therapy.

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