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Lactate Blood IncreaseNCT03974906

Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

A study testing Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO） in people with Lactate Blood Increase and Fluid Overload, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 100 years
What is being tested?
Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Mar 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）
Keywords
goal-directed fluid therapy, lactate acid level, postoperative complications, elderly patient, prone position, intraoperative hemodynamics
Medical subject headings
Hyperlactatemia, Edema, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03974906
Study groupRoleWhat they receive
GDT groupExperimentalThe 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.
Receives: Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）
Control groupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lactic acid concentrations throughout the perioperative

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

    Measured: from 24 hours before surgery to 24 hours after the surgery

Secondary outcomes (1)

  1. 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）

    Measured: 30 days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start1 Mar 2017
  3. Primary completion30 Sep 2017
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974906
Sponsor's protocol ID
PUMCH-GDT2
Status last verified
May 2021
First submitted
3 Jun 2019
Last updated
18 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23473979

  • 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.

    PubMed 27646205

  • 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.

    PubMed 27936959

  • 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.

    PubMed 28126672

  • 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.

    PubMed 27046635

  • 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.

    PubMed 21440203

  • 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.

    PubMed 30257158

  • 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.

    PubMed 27801521

Questions about this trial

What is this clinical trial studying?

A study testing Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO） in people with Lactate Blood Increase and Fluid Overload, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lactic acid concentrations throughout the perioperative (time frame: from 24 hours before surgery to 24 hours after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03974906, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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