NCT03974906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

June 3, 2019

Last Update Submit

May 13, 2021

Conditions

Lactate Blood IncreaseFluid OverloadPostoperative Complications

Keywords

goal-directed fluid therapylactate acid levelpostoperative complicationselderly patientprone positionintraoperative hemodynamics

Outcome Measures

Primary Outcomes (1)

  • Lactic acid concentrations throughout the perioperative

    the change of lactic acid concentrations(mmol/l) throughout the perioperative period

    from 24 hours before surgery to 24 hours after the surgery

Secondary Outcomes (1)

  • intraoperative fluid balance, DO2I and predefined moderate or major postoperative complications in 30-day.

    30 days after the surgery

Study Arms (2)

GDT group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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.

Interventions

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

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

GDT group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (8)

  • Ishimoto Y, Yoshimura N, Muraki S, Yamada H, Nagata K, Hashizume H, Takiguchi N, Minamide A, Oka H, Kawaguchi H, Nakamura K, Akune T, Yoshida M. Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage. 2013 Jun;21(6):783-8. doi: 10.1016/j.joca.2013.02.656. Epub 2013 Mar 5.

    PMID: 23473979BACKGROUND

  • Imajo Y, Taguchi T, Neo M, Otani K, Ogata T, Ozawa H, Miyakoshi N, Murakami H, Iguchi T. Complications of spinal surgery for elderly patients with lumbar spinal stenosis in a super-aging country: An analysis of 8033 patients. J Orthop Sci. 2017 Jan;22(1):10-15. doi: 10.1016/j.jos.2016.08.014. Epub 2016 Sep 16.

    PMID: 27646205BACKGROUND

  • Li P, Qu LP, Qi D, Shen B, Wang YM, Xu JR, Jiang WH, Zhang H, Ding XQ, Teng J. Significance of perioperative goal-directed hemodynamic approach in preventing postoperative complications in patients after cardiac surgery: a meta-analysis and systematic review. Ann Med. 2017 Jun;49(4):343-351. doi: 10.1080/07853890.2016.1271956. Epub 2017 Feb 2.

    PMID: 27936959BACKGROUND

  • Yuan J, Sun Y, Pan C, Li T. Goal-directed fluid therapy for reducing risk of surgical site infections following abdominal surgery - A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2017 Mar;39:74-87. doi: 10.1016/j.ijsu.2017.01.081. Epub 2017 Jan 23.

    PMID: 28126672BACKGROUND

  • 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.

    PMID: 27046635BACKGROUND

  • Okorie ON, Dellinger P. Lactate: biomarker and potential therapeutic target. Crit Care Clin. 2011 Apr;27(2):299-326. doi: 10.1016/j.ccc.2010.12.013.

    PMID: 21440203BACKGROUND

  • 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.

    PMID: 30257158BACKGROUND

  • 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.

    PMID: 27801521RESULT

MeSH Terms

Conditions

HyperlactatemiaEdemaPostoperative Complications

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients were assigned to one of the two groups (control group and GDT group) using a computer-generated randomization scheme.Allocation concealment was obtained using number labeled opaque envelopes that were opened just before the surgery. Data were collected by persons unaware of treatment allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor，Chairman

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 5, 2019

Study Start

March 1, 2017

Primary Completion

September 30, 2017

Study Completion

June 1, 2018

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)