Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

NCT ID: NCT03974906

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-06-01

Brief Summary

This is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( GDT ) would show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

Detailed Description

This is a single-center, randomized controlled clinical trial. Patients aged > 60 undergoing lumbar decompression surgery will be randomly assigned to either a GDT ( goal directed fluid therapy) group or a control group, who received conventional anesthesiologist-directed fluid therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. This RCT is conducted to show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

Conditions

Lactate Blood Increase; Fluid Overload; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GDT group

The fluid in GDT group (Goal-directed fluid therapy) will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the LiDCO monitoring system.

Group Type: EXPERIMENTAL

Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）

Intervention Type: OTHER

Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Control group

Patients in the control group received conventional fluid therapy, decided by the attending anesthesiologists based on the patient's hemodynamic condition and responses, to maintain MAP \>65 mm Hg, heart rate 50-100 bpm, and urine output \>0.5 ml/kg/h.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）

Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age > 60 years, American Society of Anesthesiologists score II-III, and expected duration of operation > 2 h

Exclusion Criteria

• Patients with severe cardiac arrhythmia (which would affect the accuracy of stroke volume variation as an indicator of fluid responsiveness), vascular disease (which would prohibit radial artery cannulation), and mental disorder were excluded

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huang YuGuang

Professor，Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Bacchin MR, Ceria CM, Giannone S, Ghisi D, Stagni G, Greggi T, Bonarelli S. Goal-Directed Fluid Therapy Based on Stroke Volume Variation in Patients Undergoing Major Spine Surgery in the Prone Position: A Cohort Study. Spine (Phila Pa 1976). 2016 Sep 15;41(18):E1131-E1137. doi: 10.1097/BRS.0000000000001601.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Myles PS, Bellomo R. Restrictive or Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Sep 27;379(13):1283. doi: 10.1056/NEJMc1810465. No abstract available.

Reference Type: BACKGROUND

PMID: 30257158 (View on PubMed)

Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11(11):CD012421. doi: 10.1002/14651858.CD012421.

Reference Type: RESULT

PMID: 27801521 (View on PubMed)

Other Identifiers

PUMCH-GDT2

Identifier Type: -

Identifier Source: org_study_id