Head TraumaPhase 3IsoTCNCT00847977
Interest of Using Balanced Fluid for Infusion at the Early Phase of an Acute Cranial Trauma for Limiting Hyperchloremic Acidosis
A Phase 3 study testing use of a non balced fluid and of a macromolecular fluid and use of balanced crystalloids fluid and macromolecular fluid in people with Head Trauma, run by Nantes University Hospital at 1 site in France.
Trial summary
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism. However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Trauma
- What is being tested?
- use of a non balced fluid and of a macromolecular fluid and use of balanced crystalloids fluid and macromolecular fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Oct 2010
- 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
- Glasgow < or equal to 8
- Patient > 18 years old
Who cannot join
- Polytraumatism
- Pregnancy
- Patient under guardianship
- renal insufficiency, hypokaliemia, hypocalcemia
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation CHU de Nantes Boulevard Jean Monnet
Nantes, 44093
About this study
Official title: Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.
However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.
Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.
Read the detailed description
Participation in the study lasts 7 days per patient.
Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar and without glucose. The study is an emergency: the resuscitation of a head injury, for which the plasma by crystalloids may be delayed.
J0: Day of Inclusion
On arrival at the emergency operating room at the diagnosis of a serious head injury alone, the anaesthetist that supports the patient in an initial phase includes the patient in the study.
A H0, it is holding the patient randomization and continued his rehabilitation with the lot of fluids allocated. If he wants to use macro-molecules, it may use HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA: witnesses arm includes saline solution and the HEAfusine while the interventional arm includes Isofundine and tetraspan. These treatment are indistinguishable and both provided by the laboratory Braun. They will be kept in operating emergency to be the most readily available, upon arrival of the patient. If the health of the patient requires a refill crystalloids emergency even before randomization did not take place, the clinician uses originally Saline and starts the protocol as soon as possible as soon as the patient him can take the few minutes needed to achieve inclusion. The first biological assessment include the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in Biological standard of care of a traumatized brain.
Apart from the contribution of crystalloids, the rest is therapeutic to the discretion of clinicians. The indication of monitoring the intra-cranial pressure sensor intra-parenchymatous is left to the discretion of the clinician without obligation associated with the study. As requires the usual care of this pathology, the patient is then transferred to intensive care.
J1 and J2
In accordance with the Memorandum of service, a basic daily infusion of crystalloids (30 ml / kg / day) is prescribed to all patients during the first 48 hours. The crystalloids used for these basic inputs is the lot assigned at inclusion.
If the indications of plasma referred to by hemodynamic boli solutes remain free indication of the doctor taking care of the patient, type of fluid used is the batch assigned to the patient (Isofundine-Physiologic serum), including the use of macromolecules that are available in the lot assigned to the patient (Heafusine-tetraspan).
Biological monitoring TBI usually based on a biological assessment every 12 hours. It includes a ionograms blood and blood gases. On the same samples without extract a larger volume of blood, we collect specifically in biological assessments:
- ionized calcium, magnesemia, natremia, kaliemia.
- lactatemia.
- albumin.
- plasma osmolarity. No blood gases.
Neurological based monitoring as requested by the clinician is changing the values of either the PIC transcranial doppler.
The contribution of treatment under study stops at the 48th hour, after that time, the inflow of fluid is pursued in accordance with the wishes of doctors, and the type of product is imposed by the study .
J7 or exit resuscitation
The end of the study is the 7th day of inclusion (not trauma), or the day of release resuscitation if it precedes the 7th day. This is the end of the collection of clinical data and biological weapons. From J2-J7, no treatment and no record is imposed by the study. This is a simple monitoring period assessing the future clinical neurological patients.
- Conditions
- Head Trauma
- Being tested
- use of a non balced fluid and of a macromolecular fluid, use of balanced crystalloids fluid and macromolecular fluid
- Keywords
- Acute head trauma
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of a non balced fluid and of a macromolecular fluidDrug
Also called Physiological serum and HEAfusine
Physiological serum: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Heafusine: boli 10 ml/kg on 20 minutes
use of balanced crystalloids fluid and macromolecular fluidDrug
Also called Tetraspan - Isofundine
Isofundine: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Tetraspan: boli 10 ml/kg on 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Heafusine - Physiologic serum Receives: Drug: use of a non balced fluid and of a macromolecular fluid |
| 2 | Experimental | Isofundine - Tetraspan Receives: Drug: use of balanced crystalloids fluid and macromolecular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.
Measured: J1 and J2
Secondary outcomes (2)
Incidence of hypokaliemia and hypocalcemia
Measured: J1 and J2
Study of treatment effect on the evolution of intracranil pressure.
Measured: J1 and J2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionOct 2010
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 Head TraumaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847977
- Sponsor's protocol ID
- BRD 08/3-J
- Acronym
- IsoTC
- Status last verified
- Jan 2013
- First submitted
- 18 Feb 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.
PubMed 23601796
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique
- ClinicalTrials.gov ID
- NCT00847977
- Acronym / sponsor ID
- IsoTC / BRD 08/3-J
- Conditions
- Head Trauma
- Keywords
- Acute head trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Feb 2009 (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.
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.
However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.
Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.
Detailed description
Participation in the study lasts 7 days per patient.
Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar and without glucose. The study is an emergency: the resuscitation of a head injury, for which the plasma by crystalloids may be delayed.
J0: Day of Inclusion
On arrival at the emergency operating room at the diagnosis of a serious head injury alone, the anaesthetist that supports the patient in an initial phase includes the patient in the study.
A H0, it is holding the patient randomization and continued his rehabilitation with the lot of fluids allocated. If he wants to use macro-molecules, it may use HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA: witnesses arm includes saline solution and the HEAfusine while the interventional arm includes Isofundine and tetraspan. These treatment are indistinguishable and both provided by the laboratory Braun. They will be kept in operating emergency to be the most readily available, upon arrival of the patient. If the health of the patient requires a refill crystalloids emergency even before randomization did not take place, the clinician uses originally Saline and starts the protocol as soon as possible as soon as the patient him can take the few minutes needed to achieve inclusion. The first biological assessment include the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in Biological standard of care of a traumatized brain.
Apart from the contribution of crystalloids, the rest is therapeutic to the discretion of clinicians. The indication of monitoring the intra-cranial pressure sensor intra-parenchymatous is left to the discretion of the clinician without obligation associated with the study. As requires the usual care of this pathology, the patient is then transferred to intensive care.
J1 and J2
In accordance with the Memorandum of service, a basic daily infusion of crystalloids (30 ml / kg / day) is prescribed to all patients during the first 48 hours. The crystalloids used for these basic inputs is the lot assigned at inclusion.
If the indications of plasma referred to by hemodynamic boli solutes remain free indication of the doctor taking care of the patient, type of fluid used is the batch assigned to the patient (Isofundine-Physiologic serum), including the use of macromolecules that are available in the lot assigned to the patient (Heafusine-tetraspan).
Biological monitoring TBI usually based on a biological assessment every 12 hours. It includes a ionograms blood and blood gases. On the same samples without extract a larger volume of blood, we collect specifically in biological assessments:
- ionized calcium, magnesemia, natremia, kaliemia.
- lactatemia.
- albumin.
- plasma osmolarity. No blood gases.
Neurological based monitoring as requested by the clinician is changing the values of either the PIC transcranial doppler.
The contribution of treatment under study stops at the 48th hour, after that time, the inflow of fluid is pursued in accordance with the wishes of doctors, and the type of product is imposed by the study .
J7 or exit resuscitation
The end of the study is the 7th day of inclusion (not trauma), or the day of release resuscitation if it precedes the 7th day. This is the end of the collection of clinical data and biological weapons. From J2-J7, no treatment and no record is imposed by the study. This is a simple monitoring period assessing the future clinical neurological patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: use of a non balced fluid and of a macromolecular fluidHeafusine - Physiologic serum |
| 2 | Experimental | Drug: use of balanced crystalloids fluid and macromolecular fluidIsofundine - Tetraspan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glasgow < or equal to 8
- Patient > 18 years old
Key exclusion criteria (4 listed)
- Polytraumatism
- Pregnancy
- Patient under guardianship
- renal insufficiency, hypokaliemia, hypocalcemia
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 |
|---|---|---|
| use of a non balced fluid and of a macromolecular fluidAlso: Physiological serum and HEAfusinePhysiological serum: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Heafusine: boli 10 ml/kg on 20 minutes | Drug | 1 |
| use of balanced crystalloids fluid and macromolecular fluidAlso: Tetraspan - IsofundineIsofundine: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Tetraspan: boli 10 ml/kg on 20 minutes | Drug | 2 |
Primary outcome
Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.
Time frame: J1 and J2
2 secondary outcomes
Incidence of hypokaliemia and hypocalcemia
Time frame: J1 and J2
Study of treatment effect on the evolution of intracranil pressure.
Time frame: J1 and J2
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Derived from this study: PubMed 23601796Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 use of a non balced fluid and of a macromolecular fluid and use of balanced crystalloids fluid and macromolecular fluid in people with Head Trauma, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jan 2013. 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 France. 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 stopped early. Results are not available in the source record.
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?
Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (time frame: J1 and J2). 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 NCT00847977, 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 31 Jan 2013.