Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery
IROM
Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?
1 other identifier
observational
180
1 country
1
Brief Summary
This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedJanuary 17, 2013
January 1, 2013
3 years
December 17, 2009
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maximum change in serum creatinine within 3 days
Start of anesthesia until third postoperative day (72 hours)
Secondary Outcomes (1)
incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation
1 year
Study Arms (2)
P group
Fluid Management according to measurements with PiCCO®
C group
Conventional fluid management
Interventions
Fluid and vasopressor management according to PiCCO measruements
Eligibility Criteria
Patients udndergoing Major non-cardiac surgery
You may qualify if:
- Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:
- gastrectomy
- pancreas surgery
- small bowel surgery
- esophageal surgery
- Age ≥ 18 years
- ASA classification I to III
- Written informed consent
You may not qualify if:
- Need for dialysis
- Contraindications for an arterial line in the femoral artery:
- stents
- bypasses
- severe peripheral artery occlusive disease
- ASA classification IV to V
- Pregnant Woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675, Germany
Related Publications (2)
Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.
PMID: 17119923BACKGROUNDSchmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016 Mar 8;20:50. doi: 10.1186/s13054-016-1237-1.
PMID: 26951105DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina Jungwirth, MD
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 18, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2012
Last Updated
January 17, 2013
Record last verified: 2013-01