Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study

NCT02559141 | Completed

• 1 other identifier: AZ B260/11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Nexfin monitoring system offers a complete non-invasive approach to a continuously estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour analysis. Several clinical investigations have proven reliability and interchangeability of the Nexfin technology yielding acceptable results especially regarding the trending abilities. At present there is no evidence available, whether a early goal directed hemodynamic optimization protocol based on a completely non-invasive monitoring technology is able to reduce postoperative complication. Therefore, the aim of this single-center study is to compare the clinical outcome and postoperative complications of patients undergoing major colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin technology.

Conditions

Perioperative/Postoperative Complications; C.Surgical Procedure; Digestive System

Keywords

haemodynamic optimization; cardiac index; non-invasive; pulse pressure variation

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  28 days

Secondary Outcomes (1)

• Length of hospital stay (LOS)

  28 days

Study Arms (2)

Study group (SG)

OTHER

Before induction of anaesthesia: * Arterial line * Nexfin Monitoring System * Measurement of cardiac index (CI), pulse pressure variation (PPV) and mean arterial pressure (MAP) * Baseline blood samples. Induction of anaesthesia Study Group: * PPV ≤10%, 500 ml of crystalloids/colloids as long as CI was ≥2.5 l/min/m² * Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min).

Drug: Dobutamine

Control group (CG)

NO INTERVENTION

* MAP ≥65 mmHg * CVP ≤12 mmHg * Haemoglobin level ≥8 g/dl. * Maintenance of MAP ≥65 mmHg by using crystalloids/colloids, bolus injection of theodrenaline/cafedrine or continuous infusion of norepinephrine (0.03 µg/kg/min) according to clinical evaluation.

Interventions

Dobutamine DRUG

If PPV ≤10%, volume substitution of 500 ml of crystalloids and/or colloids as long as CI was ≥2.5 l/min/m². Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg was achieved by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min).

Also known as: Norepinephrine, crystalloids/colloids

Study group (SG)

Eligibility Criteria

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

You may qualify if:

• Major abdominal procedures
• Estimated duration ≥120 minutes
• High transfusion probability
• Anticipated blood loss ≥1000 ml

You may not qualify if:

• Patients less than 18 years old
• ASA I or IV classification
• Heart rhythm disorders
• Advanced peripheral artery occlusive disease
• Arteriovenous shunts concerning upper extremities
• Laparoscopic abdominal procedures

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Ole Broch

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (11)

• Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.

  PMID: 21873370 BACKGROUND

• Toyama S, Shimoyama M. Goal-directed fluid therapy in patients undergoing colorectal surgery. Br J Anaesth. 2012 May;108(5):877-8; author reply 878-9. doi: 10.1093/bja/aes110. No abstract available.

  PMID: 22499750 BACKGROUND

• Zheng H, Guo H, Ye JR, Chen L, Ma HP. Goal-directed fluid therapy in gastrointestinal surgery in older coronary heart disease patients: randomized trial. World J Surg. 2013 Dec;37(12):2820-9. doi: 10.1007/s00268-013-2203-6.

  PMID: 24048581 BACKGROUND

• Yates DR, Davies SJ, Milner HE, Wilson RJ. Crystalloid or colloid for goal-directed fluid therapy in colorectal surgery. Br J Anaesth. 2014 Feb;112(2):281-9. doi: 10.1093/bja/aet307. Epub 2013 Sep 20.

  PMID: 24056586 BACKGROUND

• Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. No abstract available.

  PMID: 24841970 BACKGROUND

• Srinivasa S, Taylor MH, Singh PP, Lemanu DP, MacCormick AD, Hill AG. Goal-directed fluid therapy in major elective rectal surgery. Int J Surg. 2014 Dec;12(12):1467-72. doi: 10.1016/j.ijsu.2014.11.010. Epub 2014 Nov 15.

  PMID: 25463768 BACKGROUND

• Gomez-Izquierdo JC, Feldman LS, Carli F, Baldini G. Meta-analysis of the effect of goal-directed therapy on bowel function after abdominal surgery. Br J Surg. 2015 May;102(6):577-89. doi: 10.1002/bjs.9747. Epub 2015 Mar 11.

  PMID: 25759947 BACKGROUND

• Cannesson M, Ramsingh D, Rinehart J, Demirjian A, Vu T, Vakharia S, Imagawa D, Yu Z, Greenfield S, Kain Z. Perioperative goal-directed therapy and postoperative outcomes in patients undergoing high-risk abdominal surgery: a historical-prospective, comparative effectiveness study. Crit Care. 2015 Jun 19;19(1):261. doi: 10.1186/s13054-015-0945-2.

  PMID: 26088649 BACKGROUND

• Hunsicker O, Scott MJ, Miller TE, Baldini G, Feldheiser A. Gastrointestinal morbidity as primary outcome measure in studies comparing crystalloid and colloid within a goal-directed therapy. Br J Anaesth. 2015 Jul;115(1):128-9. doi: 10.1093/bja/aev181. No abstract available.

  PMID: 26089448 BACKGROUND

• Gottlieb M, Bailitz J. Comparison of Early Goal-Directed Therapy With Usual Care for Severe Sepsis and Septic Shock. Ann Emerg Med. 2015 Dec;66(6):632-4. doi: 10.1016/j.annemergmed.2015.05.025. Epub 2015 Jun 24. No abstract available.

  PMID: 26116223 BACKGROUND

• Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.

  PMID: 26206652 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Dobutamine; Norepinephrine; Crystalloid Solutions; Colloids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med. Ole Broch

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

DE (1)