Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

NCT03129009 | Unknown DMC

• 1 other identifier: XYFY-2017-008
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous non-traumatic intracerebral hemorrhage (ICH) is a common symptom in clinical practice and is the most serious among all types of stroke.Recently, as a relatively mainstream and recognized INTERACT2 (five well-known international studies in the cerebrovascular field: IMS-III, MR RESCUE, SYNTHESIS EXPANSION, INTERACT2, CHANCE) studies have shown that in patients with standard systolic blood pressure Early intensive antihypertensive therapy does not increase the incidence of death or serious adverse events. The above studies confirm the safety and efficacy of early potent depression.In 2017, Anesthesiology published a META analysis of intraoperative hypotension and blood pressure versus baseline fluctuations. The final outcome showed that 20% of blood pressure in the study was similar to MAP \<65 mmHg, regardless of the duration of the duration There will be postoperative myocardial and renal damage. Ischemia is a very important cause of organ damage. Myocardial injury is closely related to the level of mean arterial pressure, while ischemia and ischemic reperfusion injury are closely related to postoperative acute renal injury.There is no targeted guideline for ICH perioperative blood pressure management, especially intraoperative blood pressure management, and no previous studies have studied most of the studies involving ICH patients with conservative treatment, ICH patients with surgical treatment There are few reports on blood pressure control during surgery.

Conditions

Balanced Anesthesia; Intracerebral Hemorrhage; Total Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• MAP changes relative to the changes before induction

  MAP changes relative to the changes before induction; \<20%, 20% -30%, 30% -40%,\> 40%MAP changes relative to the changes before induction; \<20%, 20% -30%, 30% -40%,\> 40%

  Intraoperative

Secondary Outcomes (5)

• All-cause mortality

  7 days post surgery

• Acute renal failure

  7 days post surgery

• CK-MB release level

  6 hour, 12 hour,24 hour,48 hour post surgery

• Troponin T

  6 hour, 12 hour, 24 hour, 48 hour post surgery

• Serum creatinine

  24 hour, 48 hour,72 hour post surgery

Study Arms (2)

Total intravenous anesthesia group

ACTIVE COMPARATOR

Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion

Drug: Total intravenous anesthesia group

Balanced anesthesia group

EXPERIMENTAL

Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation

Drug: Balanced anesthesia group

Interventions

Total intravenous anesthesia group DRUG

Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion

Also known as: TIVA

Total intravenous anesthesia group

Balanced anesthesia group DRUG

Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation

Also known as: Balanced anesthesia

Balanced anesthesia group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years to90 years.
• acute stroke symptoms caused by initial spontaneous intracerebral hemorrhage as determined by CT or MRI Blood: the screen area: 30-50ml; cerebellum parts:\> 10ml.
• GCS score\> 5 points

You may not qualify if:

• ICH is caused by other factors (anticoagulation associated with cerebral hemorrhage, arteriovenous malformations, tumors)
• intracerebral hematoma is thought to be associated with trauma (simple intracerebral hemorrhage)
• there are surgical contraindications.
• history of ischemic stroke
• acute spontaneous intracerebral hemorrhage before the presence of dementia or limb dysfunction (paralysis or aphasia.
• preoperative combined with chronic kidney disease (standard for glomerular filtration rate below 60 ml · min-1 · 1.73 m2 or received dialysis).
• anesthesia time shorter than 60 min or lack of relevant basic information.
• while there is interference with the experimental results or follow-up of the disease (tumor, severe cardiovascular disease).

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Related Publications (26)

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• Sakamoto Y, Koga M, Yamagami H, Okuda S, Okada Y, Kimura K, Shiokawa Y, Nakagawara J, Furui E, Hasegawa Y, Kario K, Arihiro S, Sato S, Kobayashi J, Tanaka E, Nagatsuka K, Minematsu K, Toyoda K; SAMURAI Study Investigators. Systolic blood pressure after intravenous antihypertensive treatment and clinical outcomes in hyperacute intracerebral hemorrhage: the stroke acute management with urgent risk-factor assessment and improvement-intracerebral hemorrhage study. Stroke. 2013 Jul;44(7):1846-51. doi: 10.1161/STROKEAHA.113.001212. Epub 2013 May 23.

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  PMID: 23391776 RESULT

• Arima H, Huang Y, Wang JG, Heeley E, Delcourt C, Parsons M, Li Q, Neal B, Chalmers J, Anderson C; INTERACT1 Investigators. Earlier blood pressure-lowering and greater attenuation of hematoma growth in acute intracerebral hemorrhage: INTERACT pilot phase. Stroke. 2012 Aug;43(8):2236-8. doi: 10.1161/STROKEAHA.112.651422. Epub 2012 Jun 7.

  PMID: 22678090 RESULT

• Arima H, Anderson CS, Wang JG, Huang Y, Heeley E, Neal B, Woodward M, Skulina C, Parsons MW, Peng B, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Morgenstern LB, Chalmers J; Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial Investigators. Lower treatment blood pressure is associated with greatest reduction in hematoma growth after acute intracerebral hemorrhage. Hypertension. 2010 Nov;56(5):852-8. doi: 10.1161/HYPERTENSIONAHA.110.154328. Epub 2010 Sep 7.

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• Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

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MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Balanced Anesthesia

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jin Dong Liu, M.S

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136; liujindong1818@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 26, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)