Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction (INDUCT)
Primary Purpose
Intraoperative Hypotension
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous norepinephrine administration
Sponsored by
About this trial
This is an interventional prevention trial for Intraoperative Hypotension
Eligibility Criteria
Inclusion Criteria: non-cardiac surgery >45 years of age American Society of Anesthesiologists physical status classification II, III, and IV. Exclusion Criteria: Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter Emergency surgery Transplant surgery History of organ transplant Pregnancy Heart rhythms other than sinus rhythm Impossible Finger-cuff blood pressure monitoring Rapid sequence induction
Sites / Locations
- University Medical Center Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Continuous norepinephrine administration
Bolus norepinephrine administration
Arm Description
Outcomes
Primary Outcome Measures
Hypotension during anesthetic induction
Area under a MAP of 65 mmHg [mmHg x min]
Secondary Outcome Measures
Hypotension during anesthetic induction
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
Hypotension during anesthetic induction
Duration of a MAP <65, <60, <50, and <40 mmHg [min]
Hypertension during anesthetic induction
Duration of a MAP >100, >110, >120, and >140 mmHg [min]
Hypertension during anesthetic induction
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]
Hypertension during anesthetic induction
Absolute [n] and relative [%] number of patients with any MAP measurement >100, >110, >120 and >140 mmHg
Hypotension during anesthetic induction
Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg
Hypotension during anesthetic induction
Absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg
Hypotension during anesthetic induction
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Full Information
NCT ID
NCT05940649
First Posted
July 4, 2023
Last Updated
October 8, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT05940649
Brief Title
Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
Acronym
INDUCT
Official Title
Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury.
Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation.
In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction.
We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in non-cardiac surgery patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous norepinephrine administration
Arm Type
Experimental
Arm Title
Bolus norepinephrine administration
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Continuous norepinephrine administration
Intervention Description
In patients randomized to continuous norepinephrine administration, hypotension (= mean arterial pressure < 65mmHg) will be treated with continuous norepinephrine infusion. The norepinephrine perfusion line will be connected to the saline infusion line using a three-way valve. Treating anesthesiologists will be free to reduce or increase the norepinephrine infusion rate anytime.
Primary Outcome Measure Information:
Title
Hypotension during anesthetic induction
Description
Area under a MAP of 65 mmHg [mmHg x min]
Time Frame
First 15 minutes of anesthetic induction
Secondary Outcome Measure Information:
Title
Hypotension during anesthetic induction
Description
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
Time Frame
First 15 minutes of anesthetic induction
Title
Hypotension during anesthetic induction
Description
Duration of a MAP <65, <60, <50, and <40 mmHg [min]
Time Frame
First 15 minutes of anesthetic induction
Title
Hypertension during anesthetic induction
Description
Duration of a MAP >100, >110, >120, and >140 mmHg [min]
Time Frame
First 15 minutes of anesthetic induction
Title
Hypertension during anesthetic induction
Description
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]
Time Frame
First 15 minutes of anesthetic induction
Title
Hypertension during anesthetic induction
Description
Absolute [n] and relative [%] number of patients with any MAP measurement >100, >110, >120 and >140 mmHg
Time Frame
First 15 minutes of anesthetic induction
Title
Hypotension during anesthetic induction
Description
Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg
Time Frame
First 15 minutes of anesthetic induction
Title
Hypotension during anesthetic induction
Description
Absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg
Time Frame
First 15 minutes of anesthetic induction
Title
Hypotension during anesthetic induction
Description
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Time Frame
First 15 minutes of anesthetic induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-cardiac surgery
>45 years of age
American Society of Anesthesiologists physical status classification II, III, and IV.
Exclusion Criteria:
Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
Emergency surgery
Transplant surgery
History of organ transplant
Pregnancy
Heart rhythms other than sinus rhythm
Impossible Finger-cuff blood pressure monitoring
Rapid sequence induction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Thomsen, MD
Phone
+4915222818167
Email
kr.thomsen@uke.de
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Thomsen, MD
Phone
+4915222818167
Email
kr.thomsen@uke.de
First Name & Middle Initial & Last Name & Degree
Bernd Saugel, MD
Email
b.saugel@uke.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
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