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Fluid Infusion During Breast Surgery

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ClinicalTrials.gov Identifier: NCT00431743
Recruitment Status : Unknown
Verified February 2009 by Rigshospitalet, Denmark.
Recruitment status was:  Not yet recruiting
First Posted : February 6, 2007
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:
Rigshospitalet, Denmark

February 5, 2007
February 6, 2007
March 3, 2009
April 2009
September 2009   (Final data collection date for primary outcome measure)
To investigate orthostatic function, measured by Finapress
Same as current
Complete list of historical versions of study NCT00431743 on ClinicalTrials.gov Archive Site
  • To investigate the occurrence of postsurgery nausea/vomiting.
  • To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
  • To investigate balance function, measured by BalanceMaster
Same as current
Not Provided
Not Provided
 
Fluid Infusion During Breast Surgery
Phase 4 Study of Fluid Infusion During Breast Surgery.

The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery.

The investigators' hypothesis is that using a colloid solution will improve orthostatic function, balance, nausea/vomiting and reduce hospital stay.

The optimal amount and type of fluid given during surgery has not been defined. It has been agreed that hypovolemia must be avoided, but at the same time it has been agreed that fluid excess is harmful for organ function.When distributing fluids it is usually either crystalloids og colloids which are given. The effects of the two types of fluid have not been compared. Our hypothesis is that using a colloid (HES 130/0,4) will improve orthostatic function, nausea/vomiting and shorten hospital stay, compared to using a crystalloid (Lactated Ringer's solution).The amount of fluid the patient receives, will be individually tailored by monitoring SV using esophageal Doppler technique during surgery.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Breast Surgery
  • Drug: Hydroxyethylstarch 130/0,4
  • Drug: Lactated Ringer's solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
32
Same as current
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients having performed elective breast surgery.
  • Age between 18 and 70 years
  • Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol.

Exclusion Criteria:

  • Patients who do not understand or speak Danish
  • Patients who have not signed the informed consent or the written authority
  • pre-medication, except 1g paracetamol
  • ASA > II
  • Pregnant or breastfeeding
  • Known to have Renal disease
  • Known to have Psychiatric disorder (not considering the use of SSRI antidepressive)
  • Need for crash induction or prone position.
  • Oesophageal varicoses
  • Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus
  • Coarctation or aneurism in the proximal Aorta
  • Severe bleeding disease
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00431743
Mastectomy opti.
Not Provided
Not Provided
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Study Director: Henrik Kehlet, M.D. Ph.d. dept of surgical patophysiology
Rigshospitalet, Denmark
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP