Perioperative Fluid Management in Morbidly Obese Patients

NCT01873183 | Completed

• 1 other identifier: 12-439-32M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Anomaly; Venous Return; Dehydration

Keywords

echocardiography; morbid obesity; bariatric surgery; venous return; mean arterial blood pressure

Outcome Measures

Primary Outcomes (1)

• 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).

  12 hours

Secondary Outcomes (1)

• mean arterial blood pressure

  1 hour

Other Outcomes (1)

• Nt-proBNP, creatinine

  12 hours

Study Arms (2)

The IGDT group

EXPERIMENTAL

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

The control group

NO INTERVENTION

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.

Interventions

Goal directed fluid therapy OTHER

The IGDT group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of anaesthesiology and intensive care, Sunderby county hospital

Luleå, SE-97180 Lulea, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24902655 DERIVED

MeSH Terms

Conditions

Hypotension; Congenital Abnormalities; Dehydration; Obesity, Morbid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Tomi P Poso, MD

  Umea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, MD PhD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

SE (1)