BaSES Trial: Basel Starch Evaluation in Sepsis

Conditions

Sepsis, Septic Shock, Severe Sepsis

Keywords

Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality

Brief summary

Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet. Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function Design: Double-blind, randomized, controlled monocentric study Setting: Intensive Care Units of a University Hospital Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment. Parameter: * Intensive Care length of stay * Hospital length of stay * Mortality * Kidney function Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters. Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group

Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bødker KD, Bådstøløkken PM, Bendtsen A, Søe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bülow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schøidt O, Leivdal S, Berezowicz P, Pettilä V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjældgaard AL, Holst LB, Wernerman J, Scandinavian Critical Care Trials Group.

2011-01-2745 citations

10.1186/1745-6215-12-24

Interventions

DRUGhydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients with suspected or proven infection and 2 of the following 6 criteria: * Body temperature \<36 or \>38.3° celsius * Heart rate \> 90 beats/min * Tachypnea \> 20/min or a arterial pCO2 below 4.25 kPa * White blood cell count higher than 12.000 or below 4.000 or more than 10% immature forms * Systolic blood pressure \<90 mmHg or mean arterial pressure \< 65 mmHg * Altered mental state or oliguria

Exclusion criteria

* Pregnancy * Age below 18 * Allergy against Hydroxyethyl starch * Chronic renal insufficiency

Design outcomes

Primary

Measure	Time frame
Intensive Care length of stay	time to discharge from the Intensive care unit
Hospital length of stay	time to discharge from the hospital
Mortality	intesive care, hospital and one year mortality

Secondary

Measure	Time frame
Kidney function	at intensive care discharge and after one year
Lung function	during intensive care

Countries

Switzerland

Outcome results

None listed