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

Primary Purpose

Hypoxic-Ischemic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rectum cooling system
Hyper-hypothermia blanket
Sponsored by
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Mild Hypothermia, Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rectum cooling system

Hyper-hypothermia blanket

Arm Description

Insert the self-made device into the patient's rectum, pump ice-cold saline in to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by controlling the pumping speed of saline.

Let the patient sleep on the hyper-hypothermia blanket, set the target temperature to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by adjusting the target temperature of the device accordingly.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Complications
Any occurence of shiver,arrhythmia and coagulation abnormalities during the therapy.
Fecal Occult Blood Testing Results Before and After the Therapy

Full Information

First Posted
September 7, 2015
Last Updated
February 1, 2017
Sponsor
Children's Hospital of Chongqing Medical University
Collaborators
Chongqing Science and Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02544542
Brief Title
Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage
Official Title
A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
Collaborators
Chongqing Science and Technology Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy
Keywords
Mild Hypothermia, Hypoxic-Ischemic Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rectum cooling system
Arm Type
Experimental
Arm Description
Insert the self-made device into the patient's rectum, pump ice-cold saline in to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by controlling the pumping speed of saline.
Arm Title
Hyper-hypothermia blanket
Arm Type
Active Comparator
Arm Description
Let the patient sleep on the hyper-hypothermia blanket, set the target temperature to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by adjusting the target temperature of the device accordingly.
Intervention Type
Device
Intervention Name(s)
Rectum cooling system
Intervention Type
Device
Intervention Name(s)
Hyper-hypothermia blanket
Primary Outcome Measure Information:
Title
Rate of Cooling
Description
The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached.
Time Frame
4 hours
Title
Body Temperature Fluctuations in Maintenance Phase
Description
During the maintenance phase,the body temperature is measured every 15 minutes.
Time Frame
12 hours
Title
Rate of Rewarming
Description
The body temperature is measured every 15 minutes until it rises to 36.5℃.
Time Frame
24 to 48 hours
Secondary Outcome Measure Information:
Title
Incidence of Complications
Description
Any occurence of shiver,arrhythmia and coagulation abnormalities during the therapy.
Time Frame
24 to 72 hours
Title
Fecal Occult Blood Testing Results Before and After the Therapy
Time Frame
Within 24 hours before the therapy and 48 to 72 hours after the therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zelan Zuo, Bachelor
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19237924
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.
Results Reference
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PubMed Identifier
19535947
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.
Results Reference
background
PubMed Identifier
19384208
Citation
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.
Results Reference
background
PubMed Identifier
11518829
Citation
Thoresen M, Satas S, Loberg 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. doi: 10.1203/00006450-200109000-00017.
Results Reference
background
PubMed Identifier
11739982
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. doi: 10.1161/hs1201.99511.
Results Reference
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Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

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