Non Invasive Methods to Guide Volume Optimization

NCT01458678 | Completed

• 1 other identifier: PVI vers OD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is administered to the patient during contemporary measurement of the patients stroke volume. The fluid status is considered optimized when stroke volume no longer increases with more than 10%, indicating that the patient is close to the top of the Frank-Starling curve. Several studies show that volume optimization reduces hospital stay and reduces the amount of surgical complications. The overall purpose is to investigate if the much more simple non invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume therapy in routine health care, and to analyse if a volume kinetic test can be used to evaluate hypovolemia before surgery and make specific rehydration possible by analysing the correlation between this test and fluid optimization using stroke volume measurements. Primary hypothesis: 1. The volume of colloids that is given to volume optimise an anesthetized patient using Pleth Variability Index shows a good correlation to the volume used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data from the two methods correlate and discriminates similarly volume responders from non responders. 3. A volume kinetic model that indicates dehydration can predict the need for rehydration in order to achieve a well hydrated patient at start of surgery.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• ml colloid infusion

  Volume colloid fluid to achieve volume optimisation for guidance using Pleth Variability Index and oesophageal doppler, respectively (comparison between groups)

  During surgery (2-8 hours)

• Correlation between ml colloid infusion and dehydration level

  Correlation between level of dehydration measured by volume kinetics and urinary analysis, and correlation between these two circumstantials and the volume of colloids given for the first volume optimisation using Pleth Variability Index or oesophageal doppler

  During surgery (2-8 hours)

Secondary Outcomes (3)

• Days

  Days of hospital stay in connection with surgery, usually 2-10 days

• Complications (number)

  Complications occuring up to 30 days after surgery

• NT-pro-BNP

  Measured up to 2 days after surgery

Study Arms (2)

Oesophageal Doppler (OD)

ACTIVE COMPARATOR

Goal directed volume therapy is most often guided by stroke volume measurements by OD.

Other: Volume of colloid infusion

Pleth Variability Index (PVI)

ACTIVE COMPARATOR

The Pleth variability index (PVI) is an automated function in pulse oximetry that continuously calculates the dynamic variation between the pulse oximetry pulse variation and its baseline for every breathing circuit. Dynamic indicators are advantageous in predicting a responder to a volume bolus, thus facilitating goal directed volume therapy.

Other: Volume of colloid infusion

Interventions

Volume of colloid infusion OTHER

Colloid infusion is primarily given as hydroxyethyl starch 60 mg/ml. If more than 30 ml/kg hydroxyethyl starch 60 mg/ml is given, colloid solution is changed to albumin 4% or plasma.

Oesophageal Doppler (OD)

Eligibility Criteria

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

You may qualify if:

• Open abdominal surgery under general anaesthesia with a planned operation time of at least 120 minutes
• Age ≥ 18 years

You may not qualify if:

• Anaesthesia risk classification ASA ≥ 4
• Arrhythmia; atrial fibrillation or multiple extra systoles
• Aortic - or mitral insufficiency with hemodynamic influence
• Patients who at the preoperative visit by the responsible anaesthesiologist is planned for a more advanced cardiovascular monitoring. The following monitoring is accepted in the study: invasive blood pressure, 5-lead ECG, central venous pressure and urinary output per hour.
• Patients with a pulmonary or other disease that prevents ventilation using a tidal volume of 7 ml/kg (ideal weight) or a positive end expiratory pressure of 5 -10 cm H2O
• Contra indication against synthetic colloids as severely impaired renal or liver function, hyper natremia or allergy to synthetic colloids
• Laparoscopic surgery
• Liver surgery
• Surgery including thoracotomy
• Contraindications against an oesophageal probe such as severe oesophageal varicose veins

Sponsors & Collaborators

• Lena Nilsson: lead

Study Sites (1)

Anestesi-och operationskliniken

Linköping, SE - 581 85, Sweden

Location

Related Publications (10)

• Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.

  PMID: 14578723 BACKGROUND

• Abbas SM, Hill AG. Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia. 2008 Jan;63(1):44-51. doi: 10.1111/j.1365-2044.2007.05233.x.

  PMID: 18086070 BACKGROUND

• Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.

  PMID: 18522935 BACKGROUND

• Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.

  PMID: 12357146 BACKGROUND

• Svensen CH, Olsson J, Hahn RG. Intravascular fluid administration and hemodynamic performance during open abdominal surgery. Anesth Analg. 2006 Sep;103(3):671-6. doi: 10.1213/01.ane.0000226092.48770.fe.

  PMID: 16931679 BACKGROUND

• Hahn RG. Detection of low urine output by measuring urinary biomarkers. BMC Nutr. 2024 Jan 12;10(1):13. doi: 10.1186/s40795-024-00823-3.

  PMID: 38217039 DERIVED

• Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.

  PMID: 33957864 DERIVED

• Bahlmann H, Hahn RG, Nilsson L. Pleth variability index or stroke volume optimization during open abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2018 Aug 18;18(1):115. doi: 10.1186/s12871-018-0579-4.

  PMID: 30121072 DERIVED

• Hahn RG, Bahlmann H, Nilsson L. Preoperative fluid retention increases blood loss during major open abdominal surgery. Perioper Med (Lond). 2017 Sep 2;6:12. doi: 10.1186/s13741-017-0068-1. eCollection 2017.

  PMID: 28878889 DERIVED

• Hahn RG, Bahlmann H, Nilsson L. Dehydration and fluid volume kinetics before major open abdominal surgery. Acta Anaesthesiol Scand. 2014 Nov;58(10):1258-66. doi: 10.1111/aas.12416.

  PMID: 25307711 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lena Nilsson, MD PhD

  Anestesi- och operationskliniken, Universitetssjukuset, SE 58183 Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior consultant, PhD

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 25, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

SE (1)