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Fluid Infusion During Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Rigshospitalet, Denmark

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Surgery Drug: Hydroxyethylstarch 130/0,4 Drug: Lactated Ringer's solution Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 4 Study of Fluid Infusion During Breast Surgery.
Study Start Date : April 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To investigate orthostatic function, measured by Finapress

Secondary Outcome Measures :
  1. To investigate the occurrence of postsurgery nausea/vomiting.
  2. To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
  3. To investigate balance function, measured by BalanceMaster

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431743

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Contact: Morten Bundgaard-Nielsen, M.D. 0045 35452674
Contact: Henrik Kehlet, M.D. Ph.d 0045 35454074

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Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej Not yet recruiting
Copenhagen, Seeland, Denmark, 2200
Principal Investigator: Morten Bundgaard-Nielsen, M.D.         
Sub-Investigator: Christoffer C Jørgensen, M.S.         
Sponsors and Collaborators
Rigshospitalet, Denmark
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Study Director: Henrik Kehlet, M.D. Ph.d. dept of surgical patophysiology

Layout table for additonal information Identifier: NCT00431743     History of Changes
Other Study ID Numbers: Mastectomy opti.
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: February 2009
Keywords provided by Rigshospitalet, Denmark:
Fluid Therapy
Goal-directed Therapy