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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative/Postoperative Complications focused on measuring haemodynamic optimization, cardiac index, non-invasive, pulse pressure variation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ole Broch

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Study group (SG)

Control group (CG)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Postoperative complications

Secondary Outcome Measures

Length of hospital stay (LOS)

Full Information

First Posted
September 23, 2015
Last Updated
October 27, 2015
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT02559141
Brief Title
Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The Nexfin™ monitoring system is able to provide continuous beat-to-beat stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), cardiac index (CI) and arterial pressure by using an inflatable finger cuff. This system consists of a frequency dependent transfer function for calculation of brachial artery pressure from the finger artery pressure. Major surgery bares the risk of concealed hypoperfusion and therefore possible mismatch in oxygen delivery and oxygen demand. It must be noted, that the "basic" perioperative monitoring, i.e. electrocardiogram, oxygen saturation and non-invasive or invasive blood pressure measurements is not able to accurately detect hypovolemia and ongoing organ hypoperfusion. Perioperatively, patients undergoing major abdominal surgery are prone to high risk of hemodynamic instabilities and consequently relevant changes in oxygen delivery, associated with an increase in postoperative complications and length of stay in hospital. Over the last years several studies focused on early goal directed hemodynamic therapy (GDT) with strong proof for the feasibility of such algorithms and the improvement in patient's outcome with respect to certain clinical scenarios.However, there is still a debate regarding an individualized GDT approach, based on pre-procedural defined individualized hemodynamic goals yielded by an advanced haemodynamic monitoring technology. We do have to distinguish which monitoring system, invasive to non-invasive, matches the kind of estimated risk at what time best.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications, C.Surgical Procedure; Digestive System
Keywords
haemodynamic optimization, cardiac index, non-invasive, pulse pressure variation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group (SG)
Arm Type
Other
Arm Description
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).
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Other Intervention Name(s)
Norepinephrine, crystalloids/colloids
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative complications
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Length of hospital stay (LOS)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major abdominal procedures Estimated duration ≥120 minutes High transfusion probability Anticipated blood loss ≥1000 ml Exclusion Criteria: 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
Facility Information:
Facility Name
Ole Broch
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21873370
Citation
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.
Results Reference
background
PubMed Identifier
22499750
Citation
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.
Results Reference
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PubMed Identifier
24048581
Citation
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.
Results Reference
background
PubMed Identifier
24056586
Citation
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.
Results Reference
background
PubMed Identifier
24841970
Citation
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.
Results Reference
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PubMed Identifier
25463768
Citation
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.
Results Reference
background
PubMed Identifier
25759947
Citation
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.
Results Reference
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PubMed Identifier
26088649
Citation
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.
Results Reference
background
PubMed Identifier
26089448
Citation
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.
Results Reference
background
PubMed Identifier
26116223
Citation
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.
Results Reference
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PubMed Identifier
26206652
Citation
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.
Results Reference
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Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study

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