Poisoning by Inhaled AnaestheticPhase 3NCT01802255
Sevoflurane- Safety in Long-term Sedation Procedures
A Phase 3 study testing Sevoflurane and Midazolam in people with Poisoning by Inhaled Anaesthetic and Fluoride Poisoning, run by F Javier Belda at 1 site in Spain.
Trial summary
Patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. At present there is no optimal sedative agent for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poisoning by Inhaled Anaesthetic, Fluoride Poisoning, Recovery From Sedation
- What is being tested?
- Sevoflurane and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Jun 2015
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- Expected minimum duration of sedation: 48 hours.
Who cannot join
- Chronic renal failure treated with replacement therapy (hemodialysis or peritoneal dialysis).
- Acute kidney injury in Stage 3 of AKIN classification
- Grade C hepatic Child-Pugh classification
- Established Acute Respiratory Distress Syndrome (ARDS).
- Central nervous system pathology with cognitive disorders that not allow performing the test of the study: severe dementia, Alzheimer's disease, depression, schizophrenia, acute stroke.
- Head trauma with Glasgow <12.
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- Patient treated with antiepileptic drugs that must be maintained during the study period
- Patients requiring the use of neuromuscular blocking agents during the infusion of study drug, except for the insertion of the endotracheal tube.
- Epidural or spinal analgesia
- Allergy or known hypersensitivity to any of the study drugs
- Patients with known or suspected genetic susceptibility to malignant hyperthermia
- Previous participation in this trial
- Participation in another clinical trial within 4 weeks prior to selection.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Safety of Administration of Sevoflurane for Long-term Critically Ill Patients Sedation Undergoing Mechanical Ventilation. Prospective, Controlled, Randomized, Multicenter, Clinical Trial.
Patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. At present there is no optimal sedative agent for these patients. The most commonly used sedative agents in intensive care units are midazolam and propofol. Both drugs have side effects of clinical importance.
At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.
Read more
However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12 hours, since the possible renal problems posed by inorganic fluoride in prolonged operations remain the subject of controversy.
The primary aim (and primary hypothesis) of the current trial is to determine whether sevoflurane can be administered as a sedative drug for more than 48 hours without clinically relevant physiopathological effects on kidney and liver function.
Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.
- Conditions
- Poisoning by Inhaled Anaesthetic, Fluoride Poisoning, Recovery From Sedation, Renal Function, Hepatic Function
- Being tested
- Sevoflurane, Midazolam
- Keywords
- Inhalatory sedation, Sevoflurane, AnaConDa, Nephrotoxicity, Hepatotoxicity, Midazolam, Propofol
- Medical subject headings
- Fluoride Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane, Ultane, Sojourn
Sedation with inhaled anesthetic via AnaConDa.
MidazolamDrug
Also called Versed
Intravenous sedation.
| Study group | Role | What they receive |
|---|---|---|
| Inhalatory sedation | Experimental | Sevoflurane given via AnaConDa for sedation minimum 48 hours Receives: Drug: Sevoflurane |
| Intravenous sedation | Active comparator | Midazolam given intravenously for sedation minimum 48 hours Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of renal function.
Measurements in plasma: creatinine and cystatin levels.
Measured: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Secondary outcomes (3)
Assessment of liver function
Measurements in plasma: SGOT (aspartate aminotransferase, AST), SGPT (alanine aminotransferase, ALT), LDH (lactate dehydrogenase) alkaline phosphatase, conjugated and total bilirubin, cholesterol, triglycerides, albumin, total proteins, electrolytes and glycogen.
Measured: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Plasma pharmacokinetics of fluoride
Determine evolutionary plasmatic levels of fluorides.
Measured: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Incidence of delirium
The incidence of delirium will be evaluated by the CAM-ICU method.
Measured: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Lack of recruitment in the Centres
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Poisoning by Inhaled AnaestheticStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- F Javier Belda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, F Javier Belda, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Marina Soro, MD, PhD, Study director, Hospital Clínico Universitario de ValenciaLuciano Aguilera, MD, PhD, Principal investigator, Hospital de BasurtoCarlos Soria, MD, PhD, Principal investigator, Complejo Asistencial de LeónFrancisco Acosta, MD, PhD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802255
- Sponsor's protocol ID
- ECSEVO-LT-011
- Other IDs
- 2011-002555-34
- Status last verified
- Aug 2021
- First submitted
- 9 Feb 2013
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Shared data will be anonymous
Publications
Kong KL, Bion JF. Sedating patients undergoing mechanical ventilation in the intensive care unit--winds of change? Br J Anaesth. 2003 Mar;90(3):267-9. doi: 10.1093/bja/aeg066. No abstract available.
PubMed 12594134Rohm KD, Wolf MW, Schollhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008 Sep;34(9):1683-9. doi: 10.1007/s00134-008-1157-x. Epub 2008 May 24.
PubMed 18500419
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety of Administration of Sevoflurane for Long-term Critically Ill Patients Sedation Undergoing Mechanical Ventilation. Prospective, Controlled, Randomized, Multicenter, Clinical Trial.
- ClinicalTrials.gov ID
- NCT01802255
- Acronym / sponsor ID
- ECSEVO-LT-011
- Conditions
- Poisoning by Inhaled Anaesthetic, Fluoride Poisoning, Recovery From Sedation, Renal Function, Hepatic Function
- Keywords
- Inhalatory sedation, Sevoflurane, AnaConDa, Nephrotoxicity, Hepatotoxicity, Midazolam, Propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment in the Centres
- Enrolment
- 0 participants (actual)
- Lead sponsor
- F Javier BeldaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- 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.
Patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. At present there is no optimal sedative agent for these patients. The most commonly used sedative agents in intensive care units are midazolam and propofol. Both drugs have side effects of clinical importance.
At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.
However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12 hours, since the possible renal problems posed by inorganic fluoride in prolonged operations remain the subject of controversy.
The primary aim (and primary hypothesis) of the current trial is to determine whether sevoflurane can be administered as a sedative drug for more than 48 hours without clinically relevant physiopathological effects on kidney and liver function.
Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalatory sedation | Experimental | Drug: SevofluraneSevoflurane given via AnaConDa for sedation minimum 48 hours |
| Intravenous sedation | Active comparator | Drug: MidazolamMidazolam given intravenously for sedation minimum 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- Expected minimum duration of sedation: 48 hours.
Key exclusion criteria (14 listed)
- Chronic renal failure treated with replacement therapy (hemodialysis or peritoneal dialysis).
- Acute kidney injury in Stage 3 of AKIN classification
- Grade C hepatic Child-Pugh classification
- Established Acute Respiratory Distress Syndrome (ARDS).
- Central nervous system pathology with cognitive disorders that not allow performing the test of the study: severe dementia, Alzheimer's disease, depression, schizophrenia, acute stroke.
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 |
|---|---|---|
| SevofluraneAlso: Sevorane, Ultane, SojournSedation with inhaled anesthetic via AnaConDa. | Drug | Inhalatory sedation |
| MidazolamAlso: VersedIntravenous sedation. | Drug | Intravenous sedation |
Primary outcome
Maintenance of renal function.
Time frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Measurements in plasma: creatinine and cystatin levels.
3 secondary outcomes
Assessment of liver function
Time frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Plasma pharmacokinetics of fluoride
Time frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Incidence of delirium
Time frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 12594134Kong KL, Bion JF. Sedating patients undergoing mechanical ventilation in the intensive care unit--winds of change? Br J Anaesth. 2003 Mar;90(3):267-9. doi: 10.1093/bja/aeg066. No abstract available.
- Background: PubMed 18500419Rohm KD, Wolf MW, Schollhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008 Sep;34(9):1683-9. doi: 10.1007/s00134-008-1157-x. Epub 2008 May 24.
- Individual participant dataSharing planned: Yes. Shared data will be anonymous
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.
Marina Soro, MD, PhD study director
Hospital Clínico Universitario de Valencia
Luciano Aguilera, MD, PhD principal investigator
Hospital de Basurto
Carlos Soria, MD, PhD principal investigator
Complejo Asistencial de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane and Midazolam in people with Poisoning by Inhaled Anaesthetic and Fluoride Poisoning, run by F Javier Belda at 1 site in Spain.
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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 24 Aug 2021. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maintenance of renal function. (time frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week). 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 NCT01802255, which also lists 2 linked publications.
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 Aug 2021.