Clinical trials: Normothermia
Kidney Transplantation
Normothermic Machine Perfusion (NMP) Versus Hypothermic Machine Perfusion (HMP) in Human Kidney Transplantation
Due to the rising incidence of renal failure and the improvement of organ transplantation technology, the shortage of donor organs has become one of the main problems limiting the development of kidney transplantation.
- Trial name
- NCT05743751
- Testing
- Normothermic machine perfusion, Hypothermic machine perfusion
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Zhang Tianyu
Surgery, Temperature Change, Body
Warming Blanket Comparison Study
The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in participants undergoing renal transplantation.
- Trial name
- NCT04776954
- Testing
- Forced Air Warming System, Resistive Blanket Warming System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Minnesota
End-stage Liver Disease (ESLD), Acute Liver Failure
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given…
- Conditions
- End-stage Liver Disease (ESLD), Acute Liver Failure, Liver Cirrhosis, Liver Transplantation
- Trial name
- REFRAME-MP (NCT07585890)
- Testing
- Endischemic hypothermic oxygenated machine perfusion (any device), Endischemic (back-to-base) normothermic machine perfusion (any device), Continuous (device-to-donor) normothermic machine perfusion (any device)
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 10,000 people
- Sponsor
- University Medical Center Groningen
Traumatic Brain Injury, Subarachnoid Hemorrhage
Normothermia in Patients With Acute Cerebral Damage
The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome in…
- Trial name
- NCT00491192
- Testing
- Diclofenac
- Where
- Italy
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
The aim of this study is to demonstrate that cerebral blood flow and brain function do not resume after death declaration in organ donors who undergo normothermic regional perfusion to restore organ function following death…
- Trial name
- NONOFLOW (NCT07423936)
- Testing
- Neuromonitoring
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of British Columbia
Hypothermia
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining…
- Trial name
- NCT02905708
- Testing
- Air-Activated heating packs, Forced Air Warming Device
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr K Services PC
Hypothermia
Comparison of a New Patient Warming System Using Polymer Conductive Warming With Forced Air Warming During Surgery
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).
- Trial name
- HDV (NCT00772460)
- Testing
- Patient Warming with conductive / convective warming
- Where
- Austria
- Volunteers
- 80 people
- Sponsor
- Medical University of Vienna
Liver Diseases, Surgery
RESTORE Declined Livers Study
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants.
- Conditions
- Liver Diseases, Surgery, Transplant; Failure, Liver
- Trial name
- NCT04483102
- Testing
- Declined liver in Normothermic Machine Perfusion (NMP), Standard cold preservation of liver
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Washington University School of Medicine
Lung Transplantation
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria.
- Trial name
- HELP (NCT01190059)
- Testing
- Ex vivo lung perfusion with Steen Solution™
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- XVIVO Perfusion
Heart Arrest, Out-Of-Hospital, Physical Activity
Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2
The Target Temperature Management trial 2 (TTM2) is an international multi-center study, that randomize patients with OHCA of a presumed cardiac or unknown cause to target temperature management at 33°C or normothermia but…
- Trial name
- NCT03543332
- Testing
- Measures of physical activity and kinesiophobia
- Where
- 8 sites in Denmark, Sweden and 1 more
- Volunteers
- 109 people
- Sponsor
- Region Skane
Peritoneal Carcinomatosis
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1…
- Trial name
- NCT02739698
- Testing
- Paclitaxel, Radical surgery-peritonectomy
- Volunteers
- 32 people
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Cardiac Arrest
Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest
The IH-TTM trial is designed to determine whether survival with a favorable neurological outcome is improved by induced hypothermia at 33°C in comatose critically ill patients admitted after resuscitated in-hospital cardiac…
- Trial name
- IH-TTM (NCT07086703)
- Testing
- Induced hypothermia at 33°C, Control normothermia
- Where
- 31 sites in Belgium, France and 1 more
- Volunteers
- 788 people
- Sponsor
- Nantes University Hospital
Liver Diseases
APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts
This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris.
- Trial name
- PENOFOR (NCT04154696)
- Testing
- Liver transplantation of a graft after assessment by normothermic perfusion
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Heart Failure
Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death
Normothermic regional perfusion (NRP) utilizes Extracorporeal Membrane Oxygenation (ECMO) or cardiopulmonary bypass to reperfuse the heart and other organs in situ after isolation and ligation of the cerebral vessels.
- Trial name
- NCT04284319
- Testing
- DCD Heart Transplantation Using NRP
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- NYU Langone Health
Peritoneal Carcinomatosis
Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity.
- Trial name
- NCT01575730
- Testing
- Hyperthermic intraoperative Peritoneal Chemoperfusion
- Where
- Belgium
- Volunteers
- 45 people
- Sponsor
- University Hospital, Ghent
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal…
- Conditions
- FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer, Platinum-Resistant Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT01970722
- Testing
- Carboplatin, Cisplatin, Gemcitabine Hydrochloride
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- City of Hope Medical Center
Valvular Heart Disease
Normothermia Versus Hypothermia for Valvular Surgery Patients
Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB.
- Trial name
- NCT01338961
- Testing
- Hypothermic CPB
- Where
- Russia
- Volunteers
- 140 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Liver Transplantation
DCN for ECD Livers
The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage…
- Trial name
- NCT06804746
- Testing
- DHOPE-COR-NMP
- Where
- 2 sites in Netherlands
- Volunteers
- 143 people
- Sponsor
- Erasmus Medical Center
Peritoneal Metastases, Colo-rectal Cancer
Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer (NIPEC-OXA)
Feasibility study regarding 20 Patients with peritoneal metastases from colorectal cancer treated with cytoreductive surgery and HIPEC and subsequently with 4 courses of normothermic intraperitoneal chemotherapy - long term…
- Trial name
- NCT05056389
- Testing
- Oxaliplatin
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Oslo University Hospital
Lung Transplant
Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
- Trial name
- NCT01365429
- Testing
- XPS™ with Steen Solution™
- Where
- 18 sites in United States
- Volunteers
- 252 people
- Sponsor
- XVIVO Perfusion