Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974906
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Huang YuGuang, Peking Union Medical College Hospital

Brief Summary:
This is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( GDT ) would reduce the postoperative complications in elderly patients undergoing lumbar stenosis decompression in the prone position.

Condition or disease Intervention/treatment Phase
Postoperative Complications Fluid Overload Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO) Not Applicable

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 study will investigate whether GDT would reduce the postoperative complications in elderly patients undergoing lumbar stenosis decompression in the prone position.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Prevention
Official Title: Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Decompression Surgery in the Prone Position: A Randomized Controlled Clinical Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: GDT group
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)
Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. postoperative complications [ Time Frame: 30 days after the surgery ]
    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)


Secondary Outcome Measures :
  1. lactic acid concentrations throughout the perioperative and intraoperative fluid balance [ Time Frame: 30 days after the surgery ]
    was the change of lactic acid concentrations throughout the perioperative period and intraoperative fluid balance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974906


Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Huang YuGuang, Professor,Chairman, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03974906     History of Changes
Other Study ID Numbers: PUMCH-GDT2
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huang YuGuang, Peking Union Medical College Hospital:
goal-directed fluid therapy
intraoperative hemodynamics
postoperative complications
elderly patient
prone position

Additional relevant MeSH terms:
Layout table for MeSH terms
Postoperative Complications
Pathologic Processes