Condition category
Not Applicable
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K L Ingram

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192165308

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Double blind, randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

saline and Voluven®

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

27/06/2005

Overall trial end date

27/03/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

10

Participant 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.

Recruitment start date

27/06/2005

Recruitment end date

27/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Anaesthesia
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen's Medical Centre University Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19789444

Publication citations

  1. Results

    Lobo DN, Stanga Z, Aloysius MM, Wicks C, Nunes QM, Ingram KL, Risch L, Allison SP, Effect of volume loading with 1 liter intravenous infusions of 0.9% saline, 4% succinylated gelatine (Gelofusine) and 6% hydroxyethyl starch (Voluven) on blood volume and endocrine responses: a randomized, three-way crossover study in healthy volunteers., Crit. Care Med., 2010, 38, 2, 464-470, doi: 10.1097/CCM.0b013e3181bc80f1.

Additional files

Editorial Notes