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

ISRCTN	ISRCTN84789319
DOI	https://doi.org/10.1186/ISRCTN84789319
Protocol serial number	N0192165308
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Queen's Medical Centre University Hospital NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr K L Ingram
Scientific

University Department of Anaesthesia
C Floor East
University Hospital
Nottingham
NG7 2UH
United Kingdom

Primary study design	Interventional
Study design	Double blind, randomised crossover study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To study the responses of normal volunteers to 1 litre infusions of 0.9% saline and Voluven® over 1 hour. In particular the extent and time course of the effects of the two infusions on haematocrit, serum albumen, serum biochemistry, plasma expanding capacity and the resultant urinary responses will be measured.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Effects of Voluven® infusion on plasma volume, serum biochemistry and sodium and water controlling hormones
Intervention	Double blind, randomised crossover study
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	saline and Voluven®
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	27/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	10
Key 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.
Key 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.
Date of first enrolment	27/06/2005
Date of final enrolment	27/03/2006

University Department of Anaesthesia

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No