An interventional study of Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO） in Lactate Blood Increase, Fluid Overload and Postoperative Complications, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Prevention
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 90 is above the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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）
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.
Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
Lactic acid concentrations throughout the perioperative
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
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）
Time frame: 30 days after the surgery
Plan to share: No
Ran from Mar 2017 to primary completion in Sep 2017, 6 months.
Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 6 months is below that.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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