Super-refractory Status EpilepticusKDNCT07496749

KD Treatment for Super-refractory Status Epilepticus

A study testing the ketogenic diet and Standard Medical Therapy in people with Super-refractory Status Epilepticus, run by Xuanwu Hospital, Beijing at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of the study is to investigate to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE) in the intensive care unit (ICU). Read more about this study

Who is it for?: Ages 14 to 80 years
Conditions the study is for: Super-refractory Status Epilepticus
What is being tested?: the ketogenic diet and Standard Medical Therapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 14 sitesChina
Study dates: 20 Oct 2025to 1 Mar 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 14 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment for SE-including intravenous benzodiazepines, an anti-seizure medication (ASM, such as valproate, levetiracetam, or phenobarbital), and an anesthetic (e.g., propofol) administered continuously for 24 hours-fails to terminate the episode, or when SE recurs upon reduction of the anesthetic.
Age between 14 and 80 years, regardless of gender.
The patient's legal guardian has provided signed informed consent.

Who cannot join

Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and carnitine-related enzyme deficiencies (including carnitine palmitoyltransferase [CPT] I and II deficiency, carnitine translocase deficiency), fatty acid oxidation disorders (including beta-oxidation defects), short-chain acyl-CoA dehydrogenase deficiency (SCAD), medium-chain acyl-CoA dehydrogenase deficiency (MCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, and porphyria.
Intolerance to enteral feeding (e.g., intestinal obstruction).
Receipt of propofol infusion within 24 hours.
Hemodynamic instability (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg, requiring high-dose vasopressors for maintenance).
Liver failure (aspartate aminotransferase [AST], alanine aminotransferase [ALT], blood ammonia >5 times the upper limit of normal; total bilirubin >10 mg/dL [171 μmol/L]).
Pancreatitis.

Show all 11Show fewer

Pregnancy.
Metabolic instability (blood glucose <3.1 mmol/L, arterial blood pH <7.2, serum sodium <120 or >160 mmol/L).
Septic shock.
Complicated by diabetes insipidus.
Status epilepticus caused by hypoxic-ischemic brain injury.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Weibi Chen contact

0086-010-83198424

chenweibi@126.com

Gang Liu contact

010-83198899

liugangqingyi@sina.com

City, postcode or hospital

Sites recruiting now only

14 sites in 1 country

China14 sites, 14 recruiting

Department of Neurology, Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Weibi Chen, 0086-010-83198899, chenweibi@126.com
Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
Qinglin Yang, 0086-010-58269911, lin8082@sina.com
Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Neimenggu, 024000
Huijie Zhou, 0086-0476-8331476, 1031581493@qq.com
Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Shenggen Chen, 0086-0591-83357896, wanhuilin@fjmu.edu.cn
Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Xiao Hu, 0086-0851-85611278, 370704044@qq.com
Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311
Pengxiang Li, fire_lpx1@sina.com
Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310009
Lida Su, 0086-0571-87783777, sulida1001@zju.edu.cn
Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Linlin Sun, sunlinlinlin1981@126.com
Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yajuan Hu, Dr, 0086-0551-62922329, 78913053@qq.com
Recruiting
The First Hospital of Jilin University
Jilin City, 130021
Jie Cao, 0086-0431-84808243, cjie@jlu.edu.cn
Recruiting
Qilu Hospital，Shandong University
Jinan, Shandong, 2500012
Qinzhou Wang, 0086-0531-82166666, qinzhouwang@163.com
Not yet recruiting
Liaocheng People's Hospital
Liaocheng, 252000
Dong Guo, Dr, 0086-0635-8276225, guodonglc@126.com
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhijian Liang, 0086-0771-5322120, lzj200415@126.com
Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Jia Tian, 0086-0311-87156771, 541394689@qq.com
Recruiting

Other trials in China

About this study

Official title: Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial

Read the detailed description

This is a multicenter, prospective, randomized, controlled, open-label clinical study to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE).

The study plans to enroll eligible SRSE patients. Participants will be randomly assigned in a 1:1 ratio to one of two groups:

Control Group: Receives standard medical therapy according to current guideline recommendations for SRSE management.
Intervention Group: Receives standard medical therapy plus a ketogenic diet intervention.

The KD intervention will be administered via a nasogastric tube using a ketogenic formula. The nutritional goal is 25-30 kcal/kg, initiated at half-strength and advanced to the full caloric target within 72 hours. If no clinical improvement is observed within 2 weeks of initiating the KD, it will be discontinued. For responders, continuation is recommended. All patients in the KD group will receive concomitant daily nutritional supplements.

The primary outcome measure is the efficacy of controlling SRSE within 2 weeks after randomization. Efficacy is defined as the cessation of both clinical and electrographic status epilepticus, as confirmed by continuous EEG monitoring.

Key secondary outcomes include:

Safety evaluation, including all KD-related adverse events and in-hospital mortality.
Feasibility of KD (time to achieve ketosis, defined as blood beta-hydroxybutyrate level ≥1.2 mmol/L or urine ketones 1+).
Neurological and functional outcomes assessed by the modified Rankin Scale (mRS), Glasgow Outcome Scale-Extended (GOS-E), and quality of life (QOLIE-31) at discharge, 3 months, and 6 months.
Cognitive function (MMSE, MoCA) at 3 and 6 months. Statistical analysis will be performed on both the Full Analysis Set (FAS) and the Per-Protocol Set (PPS).

Conditions: Super-refractory Status Epilepticus
Being tested: the ketogenic diet, Standard Medical Therapy
Keywords: ketogenic diet, status epilepticus, refractory status epilepticus, encephalitis, intensive care unit
Medical subject headings: Status Epilepticus, Encephalitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the ketogenic dietOther
First, ketogenic formulation was initiated continuously via naso-enteric tube at 50% of goal and increase to goal (25-30 kcal/kg/day) within 72h. The KD regimen was continued according to seizure control and tolerance before discharge. If the patient was receiving oral nutrition, the modified MAD-KD regimen (carbohydrate 10-20 g/d) was initiated. In addition, if weaning off the diet after discharge, the reduction was 0.5:1 per week.
Standard Medical TherapyDrug
Standard Medical Therapy include continuous intravenous infusion of an anesthetic agent, such as midazolam (starting regimen: 0.2 mg/kg IV bolus followed by continuous infusion of 0.1-0.6 mg/kg/h), titrated to seizure termination

Study groups in NCT07496749
Study group	Role	What they receive
standard medical therapy for SRSE and KD therapy	Experimental	the experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy Receives: Other: the ketogenic diet; Drug: Standard Medical Therapy
standard care group	Active comparator	active comparator arm receives standard medical therapy alone. Receives: Drug: Standard Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to cessation of SRSE
Calculation Method: Based on electroencephalogram (EEG) and clinical seizure activity, the therapeutic efficacy is categorized into three levels:
Grade I (Seizure-free): Electrographic and clinical status epilepticus is completely controlled, and follow-up EEG shows resolution of electrographic status epilepticus; record the number of days required to achieve this.
Grade II (Partially effective): Epileptiform discharges are reduced by more than 50%; record the number of days required to achieve this.
Grade III (Ineffective): Epileptiform discharges are reduced by less than 50%; the recorded number of days required is 14 days.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20251 Mar 2027

First posted27 Mar 2026
Study start20 Oct 2025
Primary completion1 Feb 2027 (estimated)
Study completion1 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Super-refractory Status EpilepticusStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07496749
Sponsor's protocol ID: KS2025230-001
Acronym: KD
Status last verified: Mar 2026
First submitted: 23 Dec 2024
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data (IPD) generated in this study contains sensitive clinical information. To ensure the confidentiality and privacy of our participants as mandated by Chinese regulations and our institutional ethics committee, the raw data cannot be made publicly available. The datasets are also subject to ongoing analyses by the research team for secondary endpoints and future studies. However, anonymized data supporting the main findings can be made available from the corresponding author upon reasonable request, subject to review and approval by the study's steering committee and a signed data access agreement.

Publications

Singh RK, Joshi SM, Potter DM, Leber SM, Carlson MD, Shellhaas RA. Cognitive outcomes in febrile infection-related epilepsy syndrome treated with the ketogenic diet. Pediatrics. 2014 Nov;134(5):e1431-5. doi: 10.1542/peds.2013-3106.
PubMed 25332495
Li Y, Yang X, Zhang J, Jiang T, Zhang Z, Wang Z, Gong M, Zhao L, Zhang C. Ketogenic Diets Induced Glucose Intolerance and Lipid Accumulation in Mice with Alterations in Gut Microbiota and Metabolites. mBio. 2021 Mar 30;12(2):e03601-20. doi: 10.1128/mBio.03601-20.
PubMed 33785628
Nabbout R, Mazzuca M, Hubert P, Peudennier S, Allaire C, Flurin V, Aberastury M, Silva W, Dulac O. Efficacy of ketogenic diet in severe refractory status epilepticus initiating fever induced refractory epileptic encephalopathy in school age children (FIRES). Epilepsia. 2010 Oct;51(10):2033-7. doi: 10.1111/j.1528-1167.2010.02703.x. Epub 2010 Aug 31.
PubMed 20813015
Wusthoff CJ, Kranick SM, Morley JF, Christina Bergqvist AG. The ketogenic diet in treatment of two adults with prolonged nonconvulsive status epilepticus. Epilepsia. 2010 Jun;51(6):1083-5. doi: 10.1111/j.1528-1167.2009.02388.x. Epub 2009 Oct 20.
PubMed 19845731
Mahmoud SH, Ho-Huang E, Buhler J. Systematic review of ketogenic diet use in adult patients with status epilepticus. Epilepsia Open. 2019 Nov 24;5(1):10-21. doi: 10.1002/epi4.12370. eCollection 2020 Mar.
PubMed 32140640
Yudkoff M, Daikhin Y, Horyn O, Nissim I, Nissim I. Ketosis and brain handling of glutamate, glutamine, and GABA. Epilepsia. 2008 Nov;49 Suppl 8(Suppl 8):73-5. doi: 10.1111/j.1528-1167.2008.01841.x.
PubMed 19049594
Lowe H, Keller AE, Tanzini E, Aimola S, Liu YMC, Zak M, Chan V, Kobayashi J, Donner EJ. Ketonuria and Seizure Control in the Medium Chain Triglyceride and Classic Ketogenic Diets. Can J Neurol Sci. 2022 May;49(3):433-436. doi: 10.1017/cjn.2021.122. Epub 2021 Jun 2.
PubMed 34075859
Kaul N, Nation J, Laing J, Nicolo JP, Deane AM, Udy AA, Kwan P, O'Brien TJ. Modified low ratio ketogenic therapy in the treatment of adults with super-refractory status epilepticus. JPEN J Parenter Enteral Nutr. 2022 Nov;46(8):1819-1827. doi: 10.1002/jpen.2373. Epub 2022 Apr 7.
PubMed 35285036
van der Louw E, Aldaz V, Harvey J, Roan M, van den Hurk D, Cross JH, Auvin S; Review Group. Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. Dev Med Child Neurol. 2020 Jan;62(1):48-56. doi: 10.1111/dmcn.14306. Epub 2019 Jul 16.
PubMed 31313290
Kaul N, Laing J, Nicolo JP, Nation J, Kwan P, O'Brien TJ. Practical Considerations for Ketogenic Diet in Adults With Super-Refractory Status Epilepticus. Neurol Clin Pract. 2021 Oct;11(5):438-444. doi: 10.1212/CPJ.0000000000001009.
PubMed 34840870
Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.
PubMed 32588435
Buchhalter JR, D'Alfonso S, Connolly M, Fung E, Michoulas A, Sinasac D, Singer R, Smith J, Singh N, Rho JM. The relationship between d-beta-hydroxybutyrate blood concentrations and seizure control in children treated with the ketogenic diet for medically intractable epilepsy. Epilepsia Open. 2017 May 19;2(3):317-321. doi: 10.1002/epi4.12058. eCollection 2017 Sep.
PubMed 29588960
Gilbert DL, Pyzik PL, Freeman JM. The ketogenic diet: seizure control correlates better with serum beta-hydroxybutyrate than with urine ketones. J Child Neurol. 2000 Dec;15(12):787-90. doi: 10.1177/088307380001501203.
PubMed 11198492
van Delft R, Lambrechts D, Verschuure P, Hulsman J, Majoie M. Blood beta-hydroxybutyrate correlates better with seizure reduction due to ketogenic diet than do ketones in the urine. Seizure. 2010 Jan;19(1):36-9. doi: 10.1016/j.seizure.2009.10.009. Epub 2009 Dec 3.
PubMed 19962324
Breu M, Hafele C, Glatter S, Trimmel-Schwahofer P, Golej J, Male C, Feucht M, Dressler A. Ketogenic Diet in the Treatment of Super-Refractory Status Epilepticus at a Pediatric Intensive Care Unit: A Single-Center Experience. Front Neurol. 2021 Jun 3;12:669296. doi: 10.3389/fneur.2021.669296. eCollection 2021.
PubMed 34149600

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT07496749
Acronym / sponsor ID: KD / KS2025230-001
Conditions: Super-refractory Status Epilepticus
Keywords: ketogenic diet, status epilepticus, refractory status epilepticus, encephalitis, intensive care unit
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Xuanwu Hospital, BeijingUniversity, hospital or other
Study start: 20 Oct 2025 (actual)
Primary completion: 1 Feb 2027 (estimated)
Study completion: 1 Mar 2027 (estimated)
First posted: 27 Mar 2026 (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.

Detailed description

The study plans to enroll eligible SRSE patients. Participants will be randomly assigned in a 1:1 ratio to one of two groups:

Control Group: Receives standard medical therapy according to current guideline recommendations for SRSE management.
Intervention Group: Receives standard medical therapy plus a ketogenic diet intervention.

Key secondary outcomes include:

Safety evaluation, including all KD-related adverse events and in-hospital mortality.
Feasibility of KD (time to achieve ketosis, defined as blood beta-hydroxybutyrate level ≥1.2 mmol/L or urine ketones 1+).
Neurological and functional outcomes assessed by the modified Rankin Scale (mRS), Glasgow Outcome Scale-Extended (GOS-E), and quality of life (QOLIE-31) at discharge, 3 months, and 6 months.
Cognitive function (MMSE, MoCA) at 3 and 6 months. Statistical analysis will be performed on both the Full Analysis Set (FAS) and the Per-Protocol Set (PPS).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
standard medical therapy for SRSE and KD therapy	Experimental	Other: the ketogenic diet, Drug: Standard Medical Therapythe experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy
standard care group	Active comparator	Drug: Standard Medical Therapyactive comparator arm receives standard medical therapy alone.

Who may qualify

Ages: 14 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment for SE-including intravenous benzodiazepines, an anti-seizure medication (ASM, such as valproate, levetiracetam, or phenobarbital), and an anesthetic (e.g., propofol) administered continuously for 24 hours-fails to terminate the episode, or when SE recurs upon reduction of the anesthetic.
Age between 14 and 80 years, regardless of gender.
The patient's legal guardian has provided signed informed consent.

Key exclusion criteria (11 listed)

Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and carnitine-related enzyme deficiencies (including carnitine palmitoyltransferase [CPT] I and II deficiency, carnitine translocase deficiency), fatty acid oxidation disorders (including beta-oxidation defects), short-chain acyl-CoA dehydrogenase deficiency (SCAD), medium-chain acyl-CoA dehydrogenase deficiency (MCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, and porphyria.
Intolerance to enteral feeding (e.g., intestinal obstruction).
Receipt of propofol infusion within 24 hours.
Hemodynamic instability (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg, requiring high-dose vasopressors for maintenance).
Liver failure (aspartate aminotransferase [AST], alanine aminotransferase [ALT], blood ammonia >5 times the upper limit of normal; total bilirubin >10 mg/dL [171 μmol/L]).

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
the ketogenic dietFirst, ketogenic formulation was initiated continuously via naso-enteric tube at 50% of goal and increase to goal (25-30 kcal/kg/day) within 72h. The KD regimen was continued according to seizure control and tolerance before discharge. If the patient was receiving oral nutrition, the modified MAD-KD regimen (carbohydrate 10-20 g/d) was initiated. In addition, if weaning off the diet after discharge, the reduction was 0.5:1 per week.	Other	standard medical therapy for SRSE and KD therapy
Standard Medical TherapyStandard Medical Therapy include continuous intravenous infusion of an anesthetic agent, such as midazolam (starting regimen: 0.2 mg/kg IV bolus followed by continuous infusion of 0.1-0.6 mg/kg/h), titrated to seizure termination	Drug	standard care group, standard medical therapy for SRSE and KD therapy

Primary outcome

Time to cessation of SRSE
Time frame: 2 weeks
Calculation Method: Based on electroencephalogram (EEG) and clinical seizure activity, the therapeutic efficacy is categorized into three levels: Grade I (Seizure-free): Electrographic and clinical status epilepticus is completely controlled, and follow-up EEG shows resolution of electrographic status epilepticus; record the number of days required to achieve this. Grade II (Partially effective): Epileptiform discharges are reduced by more than 50%; record the number of days required to achieve this. Grade III (Ineffective): Epileptiform discharges are reduced by less than 50%; the recorded number of days required is 14 days.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Background: PubMed 25332495Singh RK, Joshi SM, Potter DM, Leber SM, Carlson MD, Shellhaas RA. Cognitive outcomes in febrile infection-related epilepsy syndrome treated with the ketogenic diet. Pediatrics. 2014 Nov;134(5):e1431-5. doi: 10.1542/peds.2013-3106.
Background: PubMed 33785628Li Y, Yang X, Zhang J, Jiang T, Zhang Z, Wang Z, Gong M, Zhao L, Zhang C. Ketogenic Diets Induced Glucose Intolerance and Lipid Accumulation in Mice with Alterations in Gut Microbiota and Metabolites. mBio. 2021 Mar 30;12(2):e03601-20. doi: 10.1128/mBio.03601-20.
Background: PubMed 20813015Nabbout R, Mazzuca M, Hubert P, Peudennier S, Allaire C, Flurin V, Aberastury M, Silva W, Dulac O. Efficacy of ketogenic diet in severe refractory status epilepticus initiating fever induced refractory epileptic encephalopathy in school age children (FIRES). Epilepsia. 2010 Oct;51(10):2033-7. doi: 10.1111/j.1528-1167.2010.02703.x. Epub 2010 Aug 31.
Background: PubMed 19845731Wusthoff CJ, Kranick SM, Morley JF, Christina Bergqvist AG. The ketogenic diet in treatment of two adults with prolonged nonconvulsive status epilepticus. Epilepsia. 2010 Jun;51(6):1083-5. doi: 10.1111/j.1528-1167.2009.02388.x. Epub 2009 Oct 20.
Background: PubMed 32140640Mahmoud SH, Ho-Huang E, Buhler J. Systematic review of ketogenic diet use in adult patients with status epilepticus. Epilepsia Open. 2019 Nov 24;5(1):10-21. doi: 10.1002/epi4.12370. eCollection 2020 Mar.
Background: PubMed 19049594Yudkoff M, Daikhin Y, Horyn O, Nissim I, Nissim I. Ketosis and brain handling of glutamate, glutamine, and GABA. Epilepsia. 2008 Nov;49 Suppl 8(Suppl 8):73-5. doi: 10.1111/j.1528-1167.2008.01841.x.
Background: PubMed 34075859Lowe H, Keller AE, Tanzini E, Aimola S, Liu YMC, Zak M, Chan V, Kobayashi J, Donner EJ. Ketonuria and Seizure Control in the Medium Chain Triglyceride and Classic Ketogenic Diets. Can J Neurol Sci. 2022 May;49(3):433-436. doi: 10.1017/cjn.2021.122. Epub 2021 Jun 2.
Background: PubMed 35285036Kaul N, Nation J, Laing J, Nicolo JP, Deane AM, Udy AA, Kwan P, O'Brien TJ. Modified low ratio ketogenic therapy in the treatment of adults with super-refractory status epilepticus. JPEN J Parenter Enteral Nutr. 2022 Nov;46(8):1819-1827. doi: 10.1002/jpen.2373. Epub 2022 Apr 7.
Background: PubMed 31313290van der Louw E, Aldaz V, Harvey J, Roan M, van den Hurk D, Cross JH, Auvin S; Review Group. Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. Dev Med Child Neurol. 2020 Jan;62(1):48-56. doi: 10.1111/dmcn.14306. Epub 2019 Jul 16.
Background: PubMed 34840870Kaul N, Laing J, Nicolo JP, Nation J, Kwan P, O'Brien TJ. Practical Considerations for Ketogenic Diet in Adults With Super-Refractory Status Epilepticus. Neurol Clin Pract. 2021 Oct;11(5):438-444. doi: 10.1212/CPJ.0000000000001009.
Background: PubMed 32588435Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.
Background: PubMed 29588960Buchhalter JR, D'Alfonso S, Connolly M, Fung E, Michoulas A, Sinasac D, Singer R, Smith J, Singh N, Rho JM. The relationship between d-beta-hydroxybutyrate blood concentrations and seizure control in children treated with the ketogenic diet for medically intractable epilepsy. Epilepsia Open. 2017 May 19;2(3):317-321. doi: 10.1002/epi4.12058. eCollection 2017 Sep.
Ketogenic diet treatment for super-refractory status epilepticus in the intensive care unit: feasibility, safety and effectivenessLink provided by the sponsor.
Individual participant dataSharing planned: No. The individual participant data (IPD) generated in this study contains sensitive clinical information. To ensure the confidentiality and privacy of our participants as mandated by Chinese regulations and our institutional ethics committee, the raw data cannot be made publicly available. The datasets are also subject to ongoing analyses by the research team for secondary endpoints and future studies. However, anonymized data supporting the main findings can be made available from the corresponding author upon reasonable request, subject to review and approval by the study's steering committee and a signed data access agreement.

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.

Weibi Chen contact

0086-010-83198424

chenweibi@126.com

Gang Liu contact

010-83198899

liugangqingyi@sina.com

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing the ketogenic diet and Standard Medical Therapy in people with Super-refractory Status Epilepticus, run by Xuanwu Hospital, Beijing at 14 sites in China.

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 11 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weibi Chen (0086-010-83198424, chenweibi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cessation of SRSE (time frame: 2 weeks). 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 NCT07496749, which also lists 35 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 15 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.