Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fluid Infusion During Breast Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Rigshospitalet, Denmark.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00431743
First received: February 5, 2007
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 4 Study of Fluid Infusion During Breast Surgery.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: April 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431743

Contacts
Contact: Morten Bundgaard-Nielsen, M.D. 0045 35452674 morten.bundgaard-nielsen@rh.hosp.dk
Contact: Henrik Kehlet, M.D. Ph.d 0045 35454074 henrik.kehlet@rh.hosp.dk

Locations
Denmark
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
Investigators
Study Director: Henrik Kehlet, M.D. Ph.d. dept of surgical patophysiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431743     History of Changes
Other Study ID Numbers: Mastectomy opti.
Study First Received: February 5, 2007
Last Updated: February 27, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Fluid Therapy
Crystalloid
Colloid
Perioperative
Optimization
Goal-directed Therapy

ClinicalTrials.gov processed this record on November 20, 2014