Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003446

Trial Description

start of 1:1-Block title

Title

EFFECT OF FLUID COMPOSITION ON ELECTROLYTE, ACID-BASE AND
FLUID HOMEOSTASIS
IN PATIENTS EARLY AFTER SUBARACHNOID HEMORRHAGE

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Two different kinds of fluid therapy was applied for patients with subarachnoidal hemorrhage. The hypothesis was, that these different kinds of fluids could affect electolyte balance (like natrium).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Serum electrolytes and fluid balance are frequently abnormal in patients after subarachnoid hemorrhage (SAH). The aim of this study was to evaluate early electrolyte and water homeostasis in these patients using two different fluid regimens.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003446
  •   2011/12/29
  •   [---]*
  •   yes
  •   Approved
  •   247/07, Kantonale Ethikkommission Bern (KEK) Postfach 56 Murtenstrasse 31 3010 Bern Schweiz URL:http://www.kek-bern.ch/kontakt.html
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1126-7247 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I60 -  Subarachnoid haemorrhage
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Normal saline and hydroxyethyl starch dissolved in normal saline(Voluven)were administered I.V for volume therapy according to clinical signs of hypovolemia as follows: low blood pressure and/or low urinary output(<0.5ml/kg/h) in the presence of low peripheral skin temperature, and/or decreased capillary refill or central/peripheral venous filling. The fluids used were blinded.
  •   Balanced crystalloid and colloid solutions (Ringerfundin and Tetraspan) were administered administered I.V for volume therapy according to clinical signs of hypovolemia as follows: low blood pressure and/or low urinary output(<0.5ml/kg/h) in the presence of low peripheral skin temperature, and/or decreased capillary refill or central/peripheral venous filling. The fluids used were blinded.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Serum electrolyte and water homeostatis during the first 48h after randomization. Serum and urine electrolytes, kidney parameters, acid-base status and fluid balance was measured at baseline, 24h and 48h

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Fluid balance after therapy and outcome at discharge, length of stay in hospital

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2008/01/16
  •   36
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients more than 18 years old with acute subarachnoid hemorrhage. Evaluated by an independent physician prior to study start and with defeffed written informed consent within 48h after admission to ICU.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

age<18

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Dept.of Intensive Care Medicine, University Hospital of Bern, Inselspital
    • Mr.  Professor  Stephan  Jakob 
    • 3010  Bern
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Department of Intensive Care Medicine, Univ.Hospital Bern, Inselspital
    • Mr.  Professor  Stephan  Jakob 
    • Freiburgstrasse
    • 3010  Bern
    • Switzerland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   +41 (0)31 632 41 44 oder +41 (0)31 632 53 00
    •   +41316329644
    •   Stephan.Jakob at insel.ch
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Dept.of Intensie Care Medicine, University Hospital of Bern, Inselspital
    • Mr.  Professor  Stephan  Jakob 
    • Freiburgstrasse
    • 3010  Bern
    • Switzerland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   +41 (0)31 632 41 44 oder +41 (0)31 632 53 00
    •   +41316329644
    •   Stephan.Jakob at insel.ch
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Supported by an unrestricted grant from BBraun Medical AG, Sempach, Switzerland
    • 6204  Sempach
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2010/05/04
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.