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

NCT02544542 | Completed

• 1 other identifier: X3348
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

Mild Hypothermia; Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (3)

• Rate of Cooling

  The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached.

  4 hours

• Body Temperature Fluctuations in Maintenance Phase

  During the maintenance phase,the body temperature is measured every 15 minutes.

  12 hours

• Rate of Rewarming

  The body temperature is measured every 15 minutes until it rises to 36.5℃.

  24 to 48 hours

Secondary Outcomes (2)

• Incidence of Complications

  24 to 72 hours

• Fecal Occult Blood Testing Results Before and After the Therapy

  Within 24 hours before the therapy and 48 to 72 hours after the therapy

Study Arms (2)

Rectum cooling system

EXPERIMENTAL

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.

Device: Rectum cooling system

Hyper-hypothermia blanket

ACTIVE COMPARATOR

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.

Device: Hyper-hypothermia blanket

Interventions

Rectum cooling system DEVICE

Rectum cooling system

Hyper-hypothermia blanket DEVICE

Hyper-hypothermia blanket

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• End-stage heart failure
• Uncorrected serious cardiovascular dysfunction
• Active intracranial hemorrhage not under control
• Platelet count \< 50 \* 10\^9 / L

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead
• Chongqing Science and Technology Commission: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

Related Publications (5)

• 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.

  PMID: 19237924 BACKGROUND

• 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.

  PMID: 19535947 BACKGROUND

• 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.

  PMID: 19384208 BACKGROUND

• 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.

  PMID: 11518829 BACKGROUND

• 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.

  PMID: 11739982 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zelan Zuo, Bachelor

  Children's Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse of Pediatric Intensive Care Unit

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

CN (1)