Restrictive or Doppler-guided Fluid Treatment in Colorectal Surgery

NCT03677622 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a clinical randomised double blinded multicentre trial of two different fluid treatments during colorectal surgery in an enhanced recovery programme A restricted fluid regimen aiming at zero fluid balance and less than two kilograms bodyweight change was compared with another fluid regimen where intravenous fluids were given to reach near maximal stroke volume of the heart, guided by a Doppler in the oesophagus. The primary outcome was a composite outcome of postoperative complications and death. Included was 150 patients undergoing elective colorectal surgery. No difference was found between the two groups. Both fluid therapies resulted in low complication rates. The difference in fluid volume between the groups was only 600 ml on the day of operation. The results are published, see reference section.

Conditions

Fluid Overload

Keywords

Restricted fluid therapy; Goal directed fluid therapy; Colorectal surgery; Surgery; Enhanced recovery; Fluid therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with a postoperative complication

  Only complications demanding surgical or medical treatment. Diagnostic criteria for each complication was given by protocol

  30 day follow-up

Study Arms (2)

Stroke volume (SV) group

EXPERIMENTAL

As bellow but with the addition of HES (Voluven (R)) to near maximal stroke volume of the heart: A bolus injection of 200 ml Voluven® is given repeatedly with measurement of the SV until the increase in SV in response to the bolus is \<10%. The Case Report File give detailed instructions for the interpretation of the SV during changes in position of the patient during laparoscopic surgery.

Drug: Voluven to near maximal stroke volume of the heart

Restricted group

ACTIVE COMPARATOR

Preoperatively: Clear oral fluids until 2 h before surgery. During surgery: If preoperative fluid intake \<500 ml, NaCl 0.9% is given until 500 ml. Lost blood is replaced volume by volume with HES (Voluven®) with allowance of 500 ml extra. Postoperative fluid: The rest of the day of surgery, fluid is given to meet the basic needs, i.e. 1000 ml K-Na-glucose, K-glucose or glucose 5%. The patient is encouraged to drink and eat as soon possible. In the surgical department, fluid charts and weight changes monitor fluid balance. A body weight increase of two kilograms is allowed. Fluid losses is replaced with a fluid having a similar electrolyte composition as the loss and in an equal volume. If the weight increases more than two kilogram, furosemide is given to increase the diuresis.

Drug: Voluven to near maximal stroke volume of the heart

Interventions

Voluven to near maximal stroke volume of the heart DRUG

Stroke volume guided fluid treatment with Voluven on the basis of restricted fluid therapy

Restricted group; Stroke volume (SV) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for colorectal resections if it is preoperatively estimated that the surgery may be cancer radical.
• ASA level 1-4.

You may not qualify if:

• Emergency surgery,
• Alcohol consumption \> 5 units daily,
• Inability to give informed consent (language problems, unconscious, psychosis (including confusion))
• Pregnant and lactating women
• Contraindication for the use of HES (severe renal impairment, allergy, severe bleeding disorders and pregnancy)
• Other non-radically treated malignant diseases

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Bispebjerg Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Aarhus University Hospital: collaborator
• Vejle Hospital: collaborator
• Svendborg Hospital: collaborator

Related Publications (16)

• Brandstrup B, Engquist A. [Is postoperative mortality affected by liberal intravenous fluid therapy? Presentation of a Cochrane analysis and a literature review]. Ugeskr Laeger. 2003 Mar 24;165(13):1342-5. No abstract available. Danish.

  PMID: 12703278 BACKGROUND

• Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.

  PMID: 14578723 BACKGROUND

• Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.

  PMID: 15983453 BACKGROUND

• Lobo DN, Stanga Z, Simpson JA, Anderson JA, Rowlands BJ, Allison SP. Dilution and redistribution effects of rapid 2-litre infusions of 0.9% (w/v) saline and 5% (w/v) dextrose on haematological parameters and serum biochemistry in normal subjects: a double-blind crossover study. Clin Sci (Lond). 2001 Aug;101(2):173-9.

  PMID: 11473492 BACKGROUND

• Rasmussen LA, Rosenberg J, Crawford ME, Kehlet H. [Perioperative fluid therapy. A quality control study]. Ugeskr Laeger. 1996 Sep 16;158(38):5286-90. Danish.

  PMID: 8966776 BACKGROUND

• Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002 May 25;359(9320):1812-8. doi: 10.1016/S0140-6736(02)08711-1.

  PMID: 12044376 BACKGROUND

• Brandstrup B, Svensen C, Engquist A. Hemorrhage and operation cause a contraction of the extracellular space needing replacement--evidence and implications? A systematic review. Surgery. 2006 Mar;139(3):419-32. doi: 10.1016/j.surg.2005.07.035.

  PMID: 16546507 BACKGROUND

• Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. doi: 10.1046/j.1365-2044.2002.02708.x.

  PMID: 12190747 BACKGROUND

• Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.

  PMID: 12357146 BACKGROUND

• Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995 Apr;130(4):423-9. doi: 10.1001/archsurg.1995.01430040085019.

  PMID: 7535996 BACKGROUND

• Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006 Sep;93(9):1069-76. doi: 10.1002/bjs.5454.

  PMID: 16888706 BACKGROUND

• Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.

  PMID: 9361539 BACKGROUND

• Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002 Jan;88(1):65-71. doi: 10.1093/bja/88.1.65.

  PMID: 11881887 BACKGROUND

• Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.

  PMID: 16155038 BACKGROUND

• Price JD, Sear JW, Venn RM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2004;(1):CD003004. doi: 10.1002/14651858.CD003004.pub2.

  PMID: 14974001 BACKGROUND

• Brandstrup B, Svendsen PE, Rasmussen M, Belhage B, Rodt SA, Hansen B, Moller DR, Lundbech LB, Andersen N, Berg V, Thomassen N, Andersen ST, Simonsen L. Which goal for fluid therapy during colorectal surgery is followed by the best outcome: near-maximal stroke volume or zero fluid balance? Br J Anaesth. 2012 Aug;109(2):191-9. doi: 10.1093/bja/aes163. Epub 2012 Jun 17.

  PMID: 22710266 RESULT

Related Links

• Textbook, reference number 4
• Textbook, reference number 5

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birgitte Brandstrup, PhD

  Holbaek Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: March 1, 2008
• Primary Completion: July 31, 2009
• Study Completion: August 31, 2009
• Last Updated: October 5, 2018

Record last verified: 2018-10