Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974906
• Other study ID #: PUMCH-GDT2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload
• Hyperlactatemia
• Lactate Blood Increase
• Postoperative Complications

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. — View 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. Review. — View 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:CD012421. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	30 days after the surgery