Perioperative Fluid Management in Morbidly Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Umeå University
ClinicalTrials.gov Identifier:
NCT01873183
First received: June 4, 2013
Last updated: March 13, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention
Hypotension
Anomaly; Venous Return
Dehydration
Other: Goal directed fluid therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Fluid Management With Transthoracic Echocardiography and Pulse-contour Device in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Need of perioperative i.v. fluids [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Nt-proBNP, creatinine [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The IGDT group

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.

Other: Goal directed fluid therapy
No Intervention: The control group
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873183

Locations
Sweden
Department of anaesthesiology and intensive care, Sunderby county hospital
Lulea, Sweden, SE-97180 Lulea
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Tomi P Poso, MD Umea University
  More Information

No publications provided

Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT01873183     History of Changes
Other Study ID Numbers: 12-439-32M
Study First Received: June 4, 2013
Last Updated: March 13, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
echocardiography
morbid obesity
bariatric surgery
venous return
mean arterial blood pressure

Additional relevant MeSH terms:
Dehydration
Hypotension
Cardiovascular Diseases
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 29, 2014