NCT00273728: BaSES

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

Completed Phase 4 Last updated 11 August 2011

What this trial tests

Phase 4 trial testing hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline in Sepsis in 231 participants. Completed in 1 May 2011.

Timeline

1 May 2005

Primary endpoint
1 June 2010

1 May 2011

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	231
Start date	1 May 2005
Primary completion	1 June 2010
Estimated completion	1 May 2011
Sites	2 locations across Switzerland

Drugs / interventions tested

• hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline — full drug profile →

Conditions studied

• Sepsis — all drugs for Sepsis →
• Severe Sepsis — all drugs for Severe Sepsis →
• Septic Shock — all drugs for Septic Shock →

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Sepsis or Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The pathogenesis of sepsis.
   Stearns-Kurosawa DJ, Osuchowski MF, Valentine C, Kurosawa S, et al · · 2011 · cited 441× · PMID 20887193 · DOI 10.1146/annurev-pathol-011110-130327
2. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomi
   Perner A, Haase N, Wetterslev J, Aneman A, et al · · 2011 · cited 45× · PMID 21269526 · DOI 10.1186/1745-6215-12-24
3. Mechanisms of sepsis and insights from clinical trials.
   Seam N, Suffredini AF. · · 2007 · cited 17× · PMID 18709179 · DOI 10.1016/j.ddmec.2007.10.004
4. Hydroxyethyl starch and Ringer’s lactate for volume resuscitation in sepsis and septic shock – The BaSES Trial
   Hollinger A, von Felten S, Balestra GM, Dickenmann M, et al · · 2023 · DOI 10.21203/rs.3.rs-3469382/v1