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Perioperative Fluid Management in Morbidly Obese Patients

Perioperative Fluid Management With Transthoracic Echocardiography and Pulse-contour Device in Morbidly Obese Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01873183
Enrollment
50
Registered
2013-06-07
Start date
2011-01-31
Completion date
2013-12-31
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Anomaly; Venous Return, Dehydration

Keywords

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

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.

Interventions

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Need of perioperative i.v. fluids12 hoursThe 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

MeasureTime frameDescription
mean arterial blood pressure1 hourMean 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

MeasureTime frameDescription
Nt-proBNP, creatinine12 hoursA 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026