This is a protocol for a trial carried out from 1999 to 2002. At that time, surgical patients
received a large volume of intravenous saline during operations on the colon or the rectum,
often so much fluid that their bodyweight increased by 4-6 kilograms. We hypothesized; that a
restricted fluid regimen could prevent the development of cardiopulmonary complications and
improve wound healing including the healing of an anastomosis of the gut.
We designed a clinical randomized assessor blinded multi-center trial comparing a restricted
fluid regimen to a standard fluid regimen, the difference being the volume of saline
administered to the patients. Patients undergoing surgery on the colon or the rectum were
included after informed oral and written consent.
The restricted regimen aimed at zero-fluid balance with allowance for a body weight increase
of 1 kg. The standard regimen was a bit "dryer" than the actual standard; our patients in the
standard group received saline causing a body weight increase of only 3-4 kg. The fluid
therapy started at midnight the day of operation, went on through the operation and continued
on the wards until discharge. The patients were encouraged to eat and drink as much and as
soon as possible after the operation.
The primary outcome was the number of patients who died or suffered a complication measured
within 30 days of surgery. We looked at all complications, but especially heart and lung
complications and complications related to the healing of wounds and anastomosis.
The patients was examined in the outpatient clinic after 30 days, and in addition, blinded
assessors were reviewing the medical files for registration of postoperative complications.
The results are published in The Annals of Surgery 2003; 238(5)641-48. The restricted regimen
nearly halved the number of patients with complications, and heart and lung complications
were almost eliminated.
Other investigators confirmed the results, and a more restricted approach to fluid therapy to
surgical patients has been implemented worldwide.
Phase:
Phase 4
Details
Lead Sponsor:
Holbaek Sygehus
Collaborators:
Aalborg Universitetshospital Aalborg University Hospital Bispebjerg Hospital Glostrup University Hospital, Copenhagen Herlev Hospital Hillerod Hospital, Denmark University Hospital, Gentofte, Copenhagen Vejle Hospital Zealand University Hospital