An interventional study of External Warming in Sepsis and Temperature, sponsored by Matt Harmon. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Matt Harmon · Not applicable, Interventional, and Treatment
The goal of this interventional study is to learn if external warming works to treat patients with a serious systemic infection (i.e. sepsis) that do not have fever. These patients have a higher risk of dying than patients with fever. It is possible that these patients might benefit from artificial external warming with the means to increase body temperature. It is unknown what the mechanism is, but it might be related to the immune system and how the body manages blood pressure and perfusion.
The main questions to answer are:
Participants will:
- receive treatment with external warming or treatment according to clinical practice
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 50 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →This is the only study on the registry with Matt Harmon as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
Patients using immune suppressing medications:
Patients with a for therapeutic hyperthermia:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention with External Warming
Other: External Warming
Control group according to standard clinical practice
External Warming with the Arctic Sun 5000
Also known as: Therapeutic Hyperthermia
Proteomics
Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.
Time frame: From enrollment until 48 hours after enrollment
Mortality
The effect of external warming of afebrile septic patients on mortality
Time frame: 30 days
Organ failure
To assess the effect of external warming of afebrile septic patients on organ failure.
Time frame: until end of ICU stay, approximately 30 days
Length of ICU stay
To assess the effect of external warming of afebrile septic patients on length of ICU-stay
Time frame: until end of ICU stay, approximately 30 days
Nosocomial infections
To assess the effect of external warming of afebrile septic patients on nosocomial infections.
Time frame: until end of ICU stay, approximately 30 days
Length of hospital stay
To assess the effect of external warming of afebrile septic patients on length of ICU-stay
Time frame: until discharge, approximately 30 days until 3 months
Microcirculation
To assess the impact of therapeutic hyperthermia in afebrile septic patients on microcirculation measured sublingually
Time frame: From enrollment until 48 hours after enrollment
Hemodynamics
To assess the impact of external warming in afebrile septic patients on hemodynamics
Time frame: From enrollment until 48 hours after enrollment
Mitochondrial oxygen tension
To assess the impact of external warming in afebrile septic patients on mitochondrial oxygen tension
Time frame: From enrollment until 48 hours after enrollment
Plan to share: Yes — De-identified individual participant data collected during this study that underlie the results reported in publications (including participant-level efficacy and safety data), together with the corresponding data dictionary, will be made available. Data will be prepared to minimize the risk of participant identification in accordance with applicable laws, regulations, institutional policies, and informed consent provisions. Informed consent form will not be shared as it is in Dutch.
Supporting information: Study protocol, Statistical analysis plan
Time frame: De-identified IPD and supporting documentation will be available beginning 6 months after publication of the primary study results and will remain available for 5 years. Data sharing may be extended at the discretion of the sponsor, subject to applicable legal, ethical, and institutional requirements
Access criteria: Access will be considered to qualified researchers who submit a scientifically sound research proposal that is consistent with the study objectives and receives approval from the study sponsor or designated data access committee. Investigators must sign a data sharing agreement and comply with applicable data protection and confidentiality requirements. If data will be shared, data sharing will be done through a secure data-sharing platform or other controlled-access mechanism and may be used only for the approved research purposes. If applicable, additional informed consent will be obtained. URL is not available at the time of registration. Information on requesting access will be provided by the study sponsor upon publication of the primary study results.
No publications or documents are linked to this record.
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