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

Not Applicable

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy

• Registration Number: NCT02544542
• Lead Sponsor: Children's Hospital of Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Temperature Fluctuations in Maintenance Phase	12 hours	During the maintenance phase,the body temperature is measured every 15 minutes.
Rate of Rewarming	24 to 48 hours	The body temperature is measured every 15 minutes until it rises to 36.5℃.
Rate of Cooling	4 hours	The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached.

Secondary Outcome Measures

Name	Time	Method
Incidence of Complications	24 to 72 hours	Any occurence of shiver，arrhythmia and coagulation abnormalities during the therapy.
Fecal Occult Blood Testing Results Before and After the Therapy	Within 24 hours before the therapy and 48 to 72 hours after the therapy

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China