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Completed

NCT Number: NCT00273728

BaSES Trial: Basel Starch Evaluation in Sepsis

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical ICU, Univesity Hospital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Voluven, Ringer's lactate, NaCl 0.9%

Primary outcomes

  1. Intensive Care length of stay

    Time frame: time to discharge from the Intensive care unit

  2. Hospital length of stay

    Time frame: time to discharge from the hospital

  3. Mortality

    Time frame: intesive care, hospital and one year mortality

Secondary outcomes

  1. Kidney function

    Time frame: at intensive care discharge and after one year

  2. Lung function

    Time frame: during intensive care

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Fresenius AG

Registry information

Official study title

Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial

Acronym: BaSES

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Jan 9, 2006
Registry last updated
Aug 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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