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The effects of 1L infusions of 0.9% saline and Voluven® on plasma volume, serum biochemistry and sodium and water controlling hormones in healthy volunteers: a double blind, randomised crossover study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84789319
Enrollment
10
Registered
2006-09-29
Start date
2005-06-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of Voluven® infusion on plasma volume, serum biochemistry and sodium and water controlling hormones Not Applicable

Interventions

Double blind, randomised crossover study

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male subjects aged between 18 and 40 years responding to local advertisement will be screened by questionnaire and medical examination before being chosen.

Exclusion criteria

Exclusion criteria: Subjects weighing less than 65kg or more than 80kg, those with medical conditions or allergies, those on regular medications, and participants in a study less than three months before will be excluded.

Design outcomes

Primary

MeasureTime frame
Difference in effects produced by the two infusions on haemotocrit, serum albumin, chloride, osmolality, AVP, renin, ANP and aldosterone. Differences betwen the infusions will be tested for statistical significance using the Wilcoxon signed ranks test and repeated measures ANOVA. Differences will be considered significant if P<0.05.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026