Preoperative Volume Substitution in Elective Surgery Patients
1 other identifier
interventional
220
1 country
1
Brief Summary
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia. The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 29, 2015
July 1, 2015
1.9 years
March 13, 2013
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemodynamic instability
Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following: * Systolic blood pressure \< 80 mmHg or decrease of 20% in preexistent hypertension * Mean blood pressure \< 50 mmHg or decrease of 20% or \> 20 mmHg in preexistent hypertension * Bradycardia \< 45/min or decrease of 20% in preexistent bradycardia \< 60/min. * Tachycardia \> 120/min * Cardiac index \< 2.0 l/min/m²
at time of introduction of anesthesia
Secondary Outcomes (4)
Stroke volume index > 35 ml/m2
at time of anesthesia
Stroke volume variation < 12 %
at time of anesthesia
Enddiastolic area (EDA) > 10 cm2
at time of anesthesia
inferior vana cava diameter (VCI) > 15 mm
at time of anesthesia
Study Arms (2)
Control
SHAM COMPARATORpreoperative none substitution of i.v. fluids.
Volume
ACTIVE COMPARATORpreoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- thyreoid, parathyroid or gallbladder surgery
- general anesthesia
You may not qualify if:
- coronary artery disease
- congestive heart disease (≥ New York Heart Association (NYHA) 2)
- insulin dependent diabetes mellitus
- renal insufficiency (creatinine \> 2,0 mg/dl)
- cerebrovascular disease
- severe hypertension (≥ antihypertensive drugs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Marburg, Department of Anesthesia
Marburg, D-35033, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Kratz, MD
Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Thomas Kratz
Study Record Dates
First Submitted
March 13, 2013
First Posted
March 15, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07