Acute Kidney InjuryNCT03699696
A Pilot Analysis of the Association Between Anesthesia Induction Dosing and AKI in the Elderly Population
An observational study of Acute Kidney Injury and Hypotension, run by Yale University at 1 site in United States.
Trial summary
This study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and AKI among elderly patients at YNHH. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Hypotension, Anesthesia; Adverse Effect
- What is being tested?
- Propofol
- How many people
- 541 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 8 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients who underwent induction of general anesthesia at YNHH, looking specifically at elderly patients undergoing gynecology-oncology surgeries with intubation and propofol induction.
Who may be able to join
- Patients age 65 or older who underwent induction of general anesthesia at YNHH
- Only first surgery for each patient within the time period is counted
- Only include patients who underwent intubation
- Only include patients who underwent induction by propofol bolus
- Only include patients who got at least 0.3mg/kg of propofol
Who cannot join
- Patients under the age of 65, patients who underwent monitored anesthetic care/conscious mediation for their procedures.
- Patients with renal failure and/or chronic kidney disease
- Patients who have a pre-operative systolic blood pressure <100
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health System
New Haven, Connecticut, 06511
About this study
Official title: A Pilot Analysis of the Association Between Anesthesia Induction Dosing and Acute Kidney Injury (AKI) in the Elderly Population
This study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and AKI among elderly patients at YNHH.
Read the detailed description
The first stage of this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia. We will determine the percent (as a function of age, Elixhauser score, ASA status) of patients who receive more than the FDA approved induction dosage. We estimate 30% with the power defined as the width of the 95 percent confidence interval around that number that is given by 80% power and n=500.
In the second stage, the investigators will look at the association between dose and the development of hypotension (in the time after induction and before surgical incision) and post-operative AKI among elderly patients at YNHH while controlling for age, Elixhauser score, and ASA status. The results of this study will also hopefully be used in a quality improvement project to prevent overdosing of the elderly patient population with induction anesthetic.
Hypothesis 1: Elderly patients are being overdosed (per FDA guidelines) with anesthetic agents for induction of general anesthesia.
Hypothesis 2: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing AKI.
Hypothesis 3: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing hypotension post-induction, which may contribute to development of AKI or vice-versa.
This research will be done via analysis of data and associated records contained in the Multicenter Perioperative Outcomes Group databases at Yale (the latter is a research database approved under HIC#1206010438).
The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas for quality improvement in induction practices for elderly patients at YNHH and elsewhere.
- Conditions
- Acute Kidney Injury, Hypotension, Anesthesia; Adverse Effect
- Being tested
- Propofol
- Keywords
- acute kidney injury, hypotension, anesthetic dosing, induction, elderly
- Medical subject headings
- Acute Kidney Injury, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Induction of anesthesia prior to surgery with propofol
| Study group | Role | What they receive |
|---|---|---|
| 65-75 years of age | Patients who are between the ages of 65 and 75, including 65 but not including 75, and receive propofol for induction of anesthesia. Receives: Drug: Propofol | |
| 75-85 years of age | Patients who are between the ages of 75 and 85, including 75 but not including 85, and receive propofol for induction of anesthesia. Receives: Drug: Propofol | |
| 85+ years of age | Patients who are 85 years of age or older, and receive propofol for induction of anesthesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdose
Percentage of patients >=65 who received greater than the FDA approved induction dosage of propofol
Measured: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record
Secondary outcomes (2)
Hypotension
Mean arterial pressure of less than 60mmHg
Measured: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record
Acute kidney injury
AKI identifies when there is an increase of 1.5 times the baseline serum creatinine observed in first 7 postoperative days OR when the baseline creatinine increases greater than or equal to 0.3 mg/dl in 48 hours after anesthesia end. Baseline serum creatinine is defined as the most recent serum creatinine resulted in the last 60 days preoperatively.
Measured: Within 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Dec 2014
- Primary completion8 Jul 2018
- Study completion8 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Y Chen, BS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699696
- Sponsor's protocol ID
- 2000023458
- Status last verified
- Jan 2019
- First submitted
- 5 Oct 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen EY, Michel G, Zhou B, Dai F, Akhtar S, Schonberger RB. An Analysis of Anesthesia Induction Dosing in Female Older Adults. Drugs Aging. 2020 Jun;37(6):435-446. doi: 10.1007/s40266-020-00760-3.
PubMed 32300966
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Analysis of the Association Between Anesthesia Induction Dosing and Acute Kidney Injury (AKI) in the Elderly Population
- ClinicalTrials.gov ID
- NCT03699696
- Acronym / sponsor ID
- 2000023458
- Conditions
- Acute Kidney Injury, Hypotension, Anesthesia; Adverse Effect
- Keywords
- acute kidney injury, hypotension, anesthetic dosing, induction, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 8 Jul 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and AKI among elderly patients at YNHH.
Detailed description
The first stage of this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia. We will determine the percent (as a function of age, Elixhauser score, ASA status) of patients who receive more than the FDA approved induction dosage. We estimate 30% with the power defined as the width of the 95 percent confidence interval around that number that is given by 80% power and n=500.
In the second stage, the investigators will look at the association between dose and the development of hypotension (in the time after induction and before surgical incision) and post-operative AKI among elderly patients at YNHH while controlling for age, Elixhauser score, and ASA status. The results of this study will also hopefully be used in a quality improvement project to prevent overdosing of the elderly patient population with induction anesthetic.
Hypothesis 1: Elderly patients are being overdosed (per FDA guidelines) with anesthetic agents for induction of general anesthesia.
Hypothesis 2: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing AKI.
Hypothesis 3: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing hypotension post-induction, which may contribute to development of AKI or vice-versa.
This research will be done via analysis of data and associated records contained in the Multicenter Perioperative Outcomes Group databases at Yale (the latter is a research database approved under HIC#1206010438).
The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas for quality improvement in induction practices for elderly patients at YNHH and elsewhere.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 65-75 years of age | – | Drug: PropofolPatients who are between the ages of 65 and 75, including 65 but not including 75, and receive propofol for induction of anesthesia. |
| 75-85 years of age | – | Drug: PropofolPatients who are between the ages of 75 and 85, including 75 but not including 85, and receive propofol for induction of anesthesia. |
| 85+ years of age | – | Drug: PropofolPatients who are 85 years of age or older, and receive propofol for induction of anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients who underwent induction of general anesthesia at YNHH, looking specifically at elderly patients undergoing gynecology-oncology surgeries with intubation and propofol induction.
Key inclusion criteria (5 listed)
- Patients age 65 or older who underwent induction of general anesthesia at YNHH
- Only first surgery for each patient within the time period is counted
- Only include patients who underwent intubation
- Only include patients who underwent induction by propofol bolus
- Only include patients who got at least 0.3mg/kg of propofol
Key exclusion criteria (3 listed)
- Patients under the age of 65, patients who underwent monitored anesthetic care/conscious mediation for their procedures.
- Patients with renal failure and/or chronic kidney disease
- Patients who have a pre-operative systolic blood pressure <100
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: DiprivanInduction of anesthesia prior to surgery with propofol | Drug | 65-75 years of age, 75-85 years of age, 85+ years of age |
Primary outcome
Overdose
Time frame: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record
Percentage of patients >=65 who received greater than the FDA approved induction dosage of propofol
2 secondary outcomes
Hypotension
Time frame: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record
Acute kidney injury
Time frame: Within 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 32300966Chen EY, Michel G, Zhou B, Dai F, Akhtar S, Schonberger RB. An Analysis of Anesthesia Induction Dosing in Female Older Adults. Drugs Aging. 2020 Jun;37(6):435-446. doi: 10.1007/s40266-020-00760-3.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Y Chen, BS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Hypotension, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdose (time frame: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.