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Restricted Fluid Therapy in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT03537989
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Glostrup University Hospital, Copenhagen
Herlev Hospital
Hillerod Hospital, Denmark
Vejle Hospital
Aalborg University Hospital
Zealand University Hospital
Information provided by (Responsible Party):
Birgitte Brandstrup, Holbaek Sygehus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Surgery Postoperative Complications Drug: Saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Perioperative Fluid Treatment in Colorectal Surgery
Actual Study Start Date : November 1, 1999
Actual Primary Completion Date : August 31, 2001
Actual Study Completion Date : August 31, 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Restricted group

Oral fluid to 2 h before surgery. Intra-operatively: Glucose 5% (500 ml - volume drunk during fast); HAES 6% for blood loss volume to volume; IV-medicine in saline 0.9% for anesthesia and antibiotics. Blood products after current rules.

Postoperatively: 1000 ml glucose containing fluid in the recovery room. Free oral intake of fluid and food as well as enteral feeding by tube 500 ml.

In the wards: Enteral feeding by tube 1000 ml postoperative day 1-3. Free fluid and food by mouth. If less than 1500 ml fluid pr. mouth supplement with VI-fluid.

Pathological fluid loss (high output stoma, aspirate, vomit etc.) - replace with IV-fluid. Goal: zero fluid balance with up to 1-kilogram body weight increase.

Urine < 0.5 ml/kg/h: supplement with fluid. MAP < 60 and hypovolemia: treat with fluid.

Drug: Saline
To reduce the volume of saline administered during surgery of the colon and the rectum
Other Name: NaCl 0.9%

Active Comparator: Standard group

Oral fluid to 2 h before surgery. Intra-operatively: Saline 500 ml for fasting; 500 ml HAES 6% for the epidural, Saline for the third space: 7 ml/kg/h first hour, 5 ml/kg/h 2.-3. Hour, 3 ml/kg/h subsequent hours. 1000-1500 ml Saline replaced lost blood up to 500 ml, additional HAES 6% for additional blood loss; IV-medicine in saline.

Postoperatively: 1000-2000 ml isotonic fluid in the recovery room. Free oral fluid and food as well as enteral feeding by tube 500 ml.

In the wards: Enteral feeding by tube 1000 ml postoperative day 1-3. Free fluid and food by mouth. Supplemental iv-fluid according to department rules. Pathological fluid loss (high output stoma, aspirate, vomit etc.) - replace with IV-fluid.

Urine < 0.5 ml/kg/h: supplement with fluid. MAP < 60 and hypovolemia: treat with fluid.

Drug: Saline
To reduce the volume of saline administered during surgery of the colon and the rectum
Other Name: NaCl 0.9%




Primary Outcome Measures :
  1. Postoperative complications and mortality [ Time Frame: After 30 days of follow-up ]
    The complications was defined by protocol.


Secondary Outcome Measures :
  1. Cardiopulmonary complications [ Time Frame: After 30 days of follow-up ]
    AMI, debut of cardiac arrhythmias, pulmonary congestion, pulmonary oedema, ARDS, pneumonia

  2. Complications related to tissue healing [ Time Frame: After 30 days of follow-up ]
    Wound complications and anastomotic leak


Other Outcome Measures:
  1. Hospital stay [ Time Frame: after 30 days of follow-up ]
    Length of stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for planned surgery on the colon or the rectum
  • ASA group 1-3

Exclusion Criteria:

• Patients unable to give informed consent (mental disorders, dementia, language problems)

Patients with:

  • Diabetes mellitus
  • Renal insufficiency
  • Disseminated cancers or secondary cancers
  • Inflammatory bowel disease
  • Diseases hindering epidural analgesia
  • Alcohol consumption more than 35 drinks pr. Week
  • Pregnant and lactating woman.

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 ClinicalTrials.gov identifier (NCT number): NCT03537989


Sponsors and Collaborators
Holbaek Sygehus
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Glostrup University Hospital, Copenhagen
Herlev Hospital
Hillerod Hospital, Denmark
Vejle Hospital
Aalborg University Hospital
Zealand University Hospital
Investigators
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Principal Investigator: Birgitte Brandstrup, PhD Holbaek Hospital

Publications of Results:
Other Publications:
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Responsible Party: Birgitte Brandstrup, Chief Surgeon, Clinical Associate Professor, PhD, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT03537989     History of Changes
Other Study ID Numbers: 1
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We do not mind sharing the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Birgitte Brandstrup, Holbaek Sygehus:
fluid therapy
Restricted fluid therapy
saline
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes