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Perioperative Fluid Management in Morbidly Obese Patients

Primary Purpose

Hypotension, Anomaly; Venous Return, Dehydration

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Goal directed fluid therapy
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring echocardiography, morbid obesity, bariatric surgery, venous return, mean arterial blood pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • accepted for bariatric surgery; BMI ≥ 40 kg/m2. Written informed consent. Successful preparation by 3 weeks rapid-weight-loss diet before surgery (≥ 5% loss of weight)

Exclusion Criteria:

  • Subjects with untreated systemic or pulmonary hypertension, atrial fibrillation, pacemaker, unstable angina pectoris and significant failure of heart valves.

Sites / Locations

  • Department of anaesthesiology and intensive care, Sunderby county hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The IGDT group

The control group

Arm Description

30 morbidly obese subjects scheduled for bariatric surgery by laparoscopic Roux-en-Y gastric bypass (RYGB) will be consecutively enrolled for the study. The individualized goal-directed therapy (IGDT) with focus on level of venous return will be implemented in two steps in the intervention group. First, preoperative optimizing of venous return will be performed 45 minutes before surgery in a preoperative room with TTE. Second, after induction of anaesthesia perioperative fluid therapy will be implemented by utilizing the FloTrac-device.

20 morbidly obese subjects scheduled for bariatric surgery by laparoscopic Roux-en-Y gastric bypass (RYGB) will consecutively be enrolled for the study. Conventional monitoring will be conducted perioperatively.

Outcomes

Primary Outcome Measures

Need of perioperative i.v. fluids
The primary aim of the study is to evaluate need of perioperative hydration during laparoscopic bariatric surgery. Type and amount of all perioperative fluids infused will be registered. Timing for administration of fluids will be analysed in three steps (preoperative, operating room (OR) and postoperative).

Secondary Outcome Measures

mean arterial blood pressure
Mean arterial blood pressure (MAP) will be measured before induction of anaesthesia, 5 min after endotracheal intubation, 5 min after deep reverse Trendelenburg position and pneumoperitoneum in the intervention and the control groups. In addition, MAP will be registered continuously during surgery.

Full Information

First Posted
June 4, 2013
Last Updated
October 25, 2018
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01873183
Brief Title
Perioperative Fluid Management in Morbidly Obese Patients
Official Title
Perioperative Fluid Management With Transthoracic Echocardiography and Pulse-contour Device in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In bariatric surgery functional and feasible non- or mini-invasive modalities for monitoring, and ideal/lean body weight estimates are addressed to meet up individual variability in hydration needs, and to avoid hyperhydration. The aim of the study is to evaluate need of perioperative hydration by comparing conventional monitoring (the control group) to a more advanced approach (individualized goal-directed therapy, IGDT) (the intervention group). In addition to conventional cardiovascular monitoring (ECG, non-invasive blood pressure, Sp02) preoperative transthoracic echocardiography (TTE) and a intraoperative perioperative mini-invasive pulse-contour device (FloTrac™) will be used for the purpose.
Detailed Description
The individualized goal-directed therapy (IGDT), with focus on level of venous return, will be implemented in two steps in the intervention group. First, preoperative optimizing of venous return will be performed 45 minutes before surgery in a preoperative room with TTE. Second, after induction of anaesthesia perioperative fluid therapy will be guided by utilizing the FloTrac-device. Preoperative rehydration with 6 ml colloid fluids (Volulyte™, Fresenius Kabi Ab, Sweden) /kg estimated ideal body weight (IBW) will be administrated if low level of venous return is detected by TTE. After a colloid bolus the second TTE is performed to check the level of venous return. If remaining hypovolemia is found additional colloids 3ml/ kg IBW will be given. In OR, before pneumoperitoneum, prophylactic i.v. antibiotics will be administrated in total 550ml crystalloids (NaCl 0.9%, Fresenius Kabi Ab, Sweden) to all patients. Infusion of buffered glucose solution (25mg/ml, Fresenius Kabi Ab, Sweden) at rate 1.5ml/kg IBW/h will be initiated to all patients. Stroke volume variation ≥ 12 % is used as a threshold for administration of additional colloids 3ml/kg/ IBW during surgery. Postoperatively infusion of buffered glucose solution (50mg/ml) is administrated at fixed rate 100ml/h to all patients. In addition, during the stay at the postoperative ward unit 850 ml crystalloids (antibiotics, paracetamol and nonsteroidal antiinflammatory drugs) are infused. Perioperative ephedrine and/or phenylephrine is used as i.v. injection when necessary to ensure adequate perfusion pressure (MAP ≥ 65 mmHg), cardiac index (≥ 2.0) and heart rate (≥ 50/min) in addition to i.v. fluids in both groups. In principle hemodynamic parameters will be gathered always after five minutes minimum from possible administration of i.v. ephedrine or phenylephrine. Moreover, if pre-existing systolic left ventricular failure is detected in preoperative TTE, infusion of dobutamine 3 - 4ug/kg IBW will be started 10 minutes before induction of anaesthesia. In the control group perioperative cardiovascular monitoring will be conducted by ECG, non-invasive blood pressure and Sp02 measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Anomaly; Venous Return, Dehydration
Keywords
echocardiography, morbid obesity, bariatric surgery, venous return, mean arterial blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The IGDT group
Arm Type
Experimental
Arm Description
30 morbidly obese subjects scheduled for bariatric surgery by laparoscopic Roux-en-Y gastric bypass (RYGB) will be consecutively enrolled for the study. The individualized goal-directed therapy (IGDT) with focus on level of venous return will be implemented in two steps in the intervention group. First, preoperative optimizing of venous return will be performed 45 minutes before surgery in a preoperative room with TTE. Second, after induction of anaesthesia perioperative fluid therapy will be implemented by utilizing the FloTrac-device.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
20 morbidly obese subjects scheduled for bariatric surgery by laparoscopic Roux-en-Y gastric bypass (RYGB) will consecutively be enrolled for the study. Conventional monitoring will be conducted perioperatively.
Intervention Type
Other
Intervention Name(s)
Goal directed fluid therapy
Primary Outcome Measure Information:
Title
Need of perioperative i.v. fluids
Description
The primary aim of the study is to evaluate need of perioperative hydration during laparoscopic bariatric surgery. Type and amount of all perioperative fluids infused will be registered. Timing for administration of fluids will be analysed in three steps (preoperative, operating room (OR) and postoperative).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
mean arterial blood pressure
Description
Mean arterial blood pressure (MAP) will be measured before induction of anaesthesia, 5 min after endotracheal intubation, 5 min after deep reverse Trendelenburg position and pneumoperitoneum in the intervention and the control groups. In addition, MAP will be registered continuously during surgery.
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Nt-proBNP, creatinine
Description
A baseline for Nt-proBNP and creatinine will be taken before i.v fluids preoperatively on the day of surgery. Control samples will be gathered 12 hours postoperatively.
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: accepted for bariatric surgery; BMI ≥ 40 kg/m2. Written informed consent. Successful preparation by 3 weeks rapid-weight-loss diet before surgery (≥ 5% loss of weight) Exclusion Criteria: Subjects with untreated systemic or pulmonary hypertension, atrial fibrillation, pacemaker, unstable angina pectoris and significant failure of heart valves.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomi P Poso, MD
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of anaesthesiology and intensive care, Sunderby county hospital
City
Lulea
ZIP/Postal Code
SE-97180 Lulea
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24902655
Citation
Poso T, Winso O, Aroch R, Kesek D. Perioperative fluid guidance with transthoracic echocardiography and pulse-contour device in morbidly obese patients. Obes Surg. 2014 Dec;24(12):2117-25. doi: 10.1007/s11695-014-1329-4.
Results Reference
derived

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Perioperative Fluid Management in Morbidly Obese Patients

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