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Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Primary Purpose

Lactate Blood Increase, Fluid Overload, Postoperative Complications

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Lactate Blood Increase focused on measuring goal-directed fluid therapy, lactate acid level, postoperative complications, elderly patient, prone position, intraoperative hemodynamics

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GDT group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Lactic acid concentrations throughout the perioperative

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

Secondary Outcome Measures

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

Intraoperative fluid balance include the volumes of crystalloids(ml), colloids(ml) and total volumes of intravenous fluids and output of the patients during surgery. Derived DO2I(oxygen delivery index, ml/min·m2) variables were calculated according to standard formulae. The incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75）

Full Information

NCT ID

NCT03974906

First Posted

June 3, 2019

Last Updated

May 13, 2021

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03974906

Brief Title

Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Official Title

Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Decompression Surgery in the Prone Position: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

September 30, 2017 (Actual)

Study Completion Date

June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lactate Blood Increase, Fluid Overload, Postoperative Complications

Keywords

goal-directed fluid therapy, lactate acid level, postoperative complications, elderly patient, prone position, intraoperative hemodynamics

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GDT group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Lactic acid concentrations throughout the perioperative

Description

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

Time Frame

from 24 hours before surgery to 24 hours after the surgery

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

30 days after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23473979

Citation

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.

Results Reference

background

PubMed Identifier

27646205

Citation

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.

Results Reference

background

PubMed Identifier

27936959

Citation

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.

Results Reference

background

PubMed Identifier

28126672

Citation

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.

Results Reference

background

PubMed Identifier

27046635

Citation

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.

Results Reference

background

PubMed Identifier

21440203

Citation

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.

Results Reference

background

PubMed Identifier

30257158

Citation

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.

Results Reference

background

PubMed Identifier

27801521

Citation

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.

Results Reference

result

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Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

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