Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544542
• Other study ID #: X3348
• Status: Completed
• Phase: N/A
• First received: September 7, 2015
• Last updated: February 1, 2017
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

Description:

Mild hypothermia therapy has been proved to be beneficial to patients with severe traumatic brain injury. Currently a variety of cooling methods can achieve mild hypothermia,the hyper-hypothermia blanket being the most widely-used one.

Hyper-hypothermia blanket is a waterbed mattress connected to a thermostat-controlled water tank. Water is cooled in the tank and recycled between the tank and the mattress so that the patients sleeping on the mattress can be stably cooled. The operation is basically program-controlled ,but the whole system is quite expensive.

The investigators came up with a new cooling system which is very simple and accessible. A condom inserted with two 10# gastric tube and one 6# gastric tube and ringed with a rubber band is inserted into the patient's rectum, and ice-cold saline is pumped in through one 10# gastric tube and drained out from the other 10# gastric tube, the 6# gastric tube connected to the pressure monitor. Cooling rate is controlled by the flow speed of cold saline. The investigators will evaluate the effectiveness and safety of this new method for achieving mild hypothermia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neonatal HIE

• After cardiopulmonary resuscitation (CPR)

• Severe craniocerebral injury (GCS < 8)

• Acute central nervous system infection and severe brain edema or lasting convulsion

• Severe cerebral edema caused by various metabolic factors

Exclusion Criteria:

• End-stage heart failure

• Uncorrected serious cardiovascular dysfunction

• Active intracranial hemorrhage not under control

• Platelet count < 50 * 10^9 / L

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Device:
• Rectum cooling system

• Hyper-hypothermia blanket

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University	Chongqing Science and Technology Commission

Country where clinical trial is conducted

China, 

References & Publications (5)

Badjatia N, Strongilis E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Mayer SA. Metabolic benefits of surface counter warming during therapeutic temperature modulation. Crit Care Med. 2009 Jun;37(6):1893-7. doi: 10.1097/CCM.0b013e31819fffd3. — View Citation

Polderman KH, Herold I. Therapeutic hypothermia and controlled normothermia in the intensive care unit: practical considerations, side effects, and cooling methods. Crit Care Med. 2009 Mar;37(3):1101-20. doi: 10.1097/CCM.0b013e3181962ad5. Review. — View Citation

Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241. Review. — View Citation

Steiner T, Friede T, Aschoff A, Schellinger PD, Schwab S, Hacke W. Effect and feasibility of controlled rewarming after moderate hypothermia in stroke patients with malignant infarction of the middle cerebral artery. Stroke. 2001 Dec 1;32(12):2833-5. — View Citation

Thoresen M, Satas S, Løberg EM, Whitelaw A, Acolet D, Lindgren C, Penrice J, Robertson N, Haug E, Steen PA. Twenty-four hours of mild hypothermia in unsedated newborn pigs starting after a severe global hypoxic-ischemic insult is not neuroprotective. Pediatr Res. 2001 Sep;50(3):405-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cooling	The body temperature is measured every 15 minutes until the target temperature(33-35?)is reached.	4 hours
Primary	Body Temperature Fluctuations in Maintenance Phase	During the maintenance phase,the body temperature is measured every 15 minutes.	12 hours
Primary	Rate of Rewarming	The body temperature is measured every 15 minutes until it rises to 36.5?.	24 to 48 hours
Secondary	Incidence of Complications	Any occurence of shiver,arrhythmia and coagulation abnormalities during the therapy.	24 to 72 hours
Secondary	Fecal Occult Blood Testing Results Before and After the Therapy		Within 24 hours before the therapy and 48 to 72 hours after the therapy