IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis (IHPOTOTAM)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00774631 |
|
Recruitment Status :
Terminated
(The sponsor stoppes the study for the security problem.)
First Posted : October 17, 2008
Last Update Posted : September 17, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma). The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory drug and resuscitation measures in intensive care setting but the prognosis of comatose patients remains poor.
Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis animal studies and in severe traumatic brain injury, moderate hypothermia is able to diminish cerebral oedema and brain inflammation.
Thus, the objective of this study is to compare two strategies: only usual care or usual care completed by moderate hypothermia. The body temperature will be lowered between 32 and 34°C by means of a catheter placed in a big vein and connected to a machine in which circulates a cold liquid, or by means of an external cooling (ice-cold blanket, ice packs placed on the body). Whatever technique is chosen, the technique is perfectly mastered by the teams which take charge of the patients. After 48 hours, the technique of hypothermia will be suspended and body temperature will return passively and gradually to normal.
The investigators believe that moderate hypothermia will improve the prognosis of the most severe patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bacterial Meningitis | Procedure: Mild induced hypothermia (32-34°C) Procedure: local recommendations and guidelines | Phase 4 |
Investigational procedure:
This study evaluates the impact of mild induced hypothermia (32-34°C) during 48 hours followed by passive rewarming according to recommendations described in appendix. All treatment will be according to local recommendations and guidelines of medical societies and literature. Physicians are advised to use these recommendations; however, the best treatment option for the individual patient should be used.
Mild Induced hypothermia:
Investigators are advised to use the cooling techniques as used in patients with cardiac arrest. Thus, the choice of cooling method will be left to investigators. Hypothermia will be induced by cold saline infusion as described in appendix 5 [6, 48]. Core temperature will be monitored by oesophageal probe and maintained between 32°C and 34°C during 48 hours and followed by strictly passive rewarming. During this phase of treatment, patients will receive deep sedation associated with neuromuscular blockers. Centers participating to the trial will have expertise in cooling methods.
Controls:
Controls will receive standard care and will be also be deeply sedated for 48 hours.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 98 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Mild Induced Hypothermia to Treat Severe Community Acquired Meningitis in Adults Admitted to Intensive Care Unit |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Hypothermia
mild induced hypothermia (32-34°C) during 48 hours followed by passive rewarming
|
Procedure: Mild induced hypothermia (32-34°C)
Mild Induced hypothermia: Investigators are advised to use the cooling techniques as used in patients with cardiac arrest. Thus, the choice of cooling method will be left to investigators. Hypothermia will be induced by cold saline infusion as described in appendix 5 [6, 48]. Core temperature will be monitored by oesophageal probe and maintained between 32°C and 34°C during 48 hours and followed by strictly passive rewarming. During this phase of treatment, patients will receive deep sedation associated with neuromuscular blockers. Centers participating to the trial will have expertise in cooling methods. |
|
Active Comparator: No hypothermia
no hypothermia, according to local recommendations and guidelines of medical societies and literature
|
Procedure: local recommendations and guidelines
Investigational procedure: This study evaluates the impact of mild induced hypothermia (32-34°C) during 48 hours followed by passive rewarming according to recommendations described in appendix. All treatment will be according to local recommendations and guidelines of medical societies and literature. Physicians are advised to use these recommendations; however, the best treatment option for the individual patient should be used. Controls will receive standard care and will be also be deeply sedated for 48 hours. |
- Proportion of patients with unfavorable outcome (defined as score on Glasgow outcome Scale < 5) at 3 months after admission. [ Time Frame: 3 months ]
- Mortality (assessed on day 14 after admission, day 28, total in-hospital mortality, and at 3 and 6 months) [ Time Frame: 6 months ]
- ICU length of stay [ Time Frame: 6 months ]
- Score on GOS at ICU discharge and 6 months after admission [ Time Frame: 6 months ]
- Neurological examination at discharge and 6 months after admission [ Time Frame: 6 months ]
- Neuropsychological outcome at 6 months in a subset of centres; patient will be tested with a neuropsychological test battery described previously [ Time Frame: 6 months ]
- MRC score on ICU discharge [ Time Frame: 3 months ]
- Prevalence of status EPILEPTISIS [ Time Frame: 6 months ]
- Prevalence of infections (aspiration pneumonia and nosocomial infections) [ Time Frame: 6 months ]
- Potential hypothermia related side effects as cardiac arrhythmia, electrolyte balance, hyperglycemia, bleeding, acute pancreatitis (see definitions further). [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Subject is 18 years of age or older
- Clinically suspected community-acquired bacterial meningitis (More than 100 white blood cells in CSF and a glucose CSF/Blood ratio of 1/3 or less, or a CSF protein level above 2,2 g/L.)
- Presence of micro-organisms on CSF Gram's stain examination
- Positive soluble antigen or PCR for S. pneumoniae or N. meningitides
- Positive CSF cultures
- Score on Glasgow Coma Score < 8
- Patient received appropriate antimicrobial therapy (according to recommendations)
- If present, legally acceptable representative has provided written and dated informed consent to participate in the study.
EXCLUSION CRITERIA:
- Glasgow Coma Score < 8 for more than 12 hours
- Patients with HIV positivity: positive cryptococcal antigen in blood or CSF; Cerebral abscess
- pregnancy
- Subject has been designated as "not full support", "do not resuscitate" or equivalent status which prohibits the use of life supporting interventions thereby limiting options available
- Subject admitted for a clinical situation in which induced hypothermia is recommended
- Purpura fulminancy, defined as septic shock with extensive necrotizing purpura and disseminated intravascular coagulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774631
| France | |
| Hopital Bichat Claude Bernard | |
| Paris, France, 75018 | |
| Principal Investigator: | MOURVILLIER Bruno, MD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00774631 History of Changes |
| Other Study ID Numbers: |
P 060217 AOM 06 038 ( Other Identifier: French Ministry ) |
| First Posted: | October 17, 2008 Key Record Dates |
| Last Update Posted: | September 17, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Meningitis Hypothermia Intensive care |
Additional relevant MeSH terms:
|
Hypothermia Meningitis Meningitis, Bacterial Body Temperature Changes Signs and Symptoms |
Central Nervous System Diseases Nervous System Diseases Central Nervous System Bacterial Infections Bacterial Infections Central Nervous System Infections |