Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Changes of Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage During Different General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129009
• Other study ID #: XYFY-2017-008
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 20, 2017
• Start date: April 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: April 2017
• Source: Xuzhou Medical University
• Contact: Jin Dong Liu, M.S
• Phone: +86-13951355136
• Email: liujindong1818[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The general anesthesia used in craniotomy, whether intravenous anesthesia or total intravenous anesthesia, have a certain degree of blood pressure and lead to a decline in blood pressure, the study aims to spontaneous cerebral hemorrhage this special And to observe the changes of hemodynamics and the changes of heart and kidney function in ICH, and to explore the relationship between the anesthesia and the blood of ICH. The range of volatility.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 18 years to90 years.

2. acute stroke symptoms caused by initial spontaneous intracerebral hemorrhage as determined by CT or MRI Blood: the screen area: 30-50ml; cerebellum parts:> 10ml.

3. GCS score> 5 points

Exclusion Criteria:

1. ICH is caused by other factors (anticoagulation associated with cerebral hemorrhage, arteriovenous malformations, tumors)

2. intracerebral hematoma is thought to be associated with trauma (simple intracerebral hemorrhage)

3. there are surgical contraindications.

4. history of ischemic stroke

5. acute spontaneous intracerebral hemorrhage before the presence of dementia or limb dysfunction (paralysis or aphasia.

6. preoperative combined with chronic kidney disease (standard for glomerular filtration rate below 60 ml · min-1 · 1.73 m2 or received dialysis).

7. anesthesia time shorter than 60 min or lack of relevant basic information.

8. while there is interference with the experimental results or follow-up of the disease (tumor, severe cardiovascular disease).

Related Conditions & MeSH terms

• Balanced Anesthesia
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Total Intravenous Anesthesia

Intervention

Drug:
• Total intravenous anesthesia group
Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
• Balanced anesthesia group
Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (26)

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 l — View Citation

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 Tri — View Citation

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. — View Citation

Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930. — View Citation

Butcher KS, Jeerakathil T, Hill M, Demchuk AM, Dowlatshahi D, Coutts SB, Gould B, McCourt R, Asdaghi N, Findlay JM, Emery D, Shuaib A; ICH ADAPT Investigators.. The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial. Stroke. 2013 Mar;44(3 — View Citation

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Liu JD, Chen HJ, Wang DL, Wang H, Deng Q. Pim-1 Kinase Regulating Dynamics Related Protein 1 Mediates Sevoflurane Postconditioning-induced Cardioprotection. Chin Med J (Engl). 2017 Feb 5;130(3):309-317. doi: 10.4103/0366-6999.198922. — View Citation

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Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. Review. — View Citation

Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators.. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the Inte — View Citation

Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesi — View Citation

POISE Study Group., Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Málaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinat — View Citation

Qureshi AI, Ezzeddine MA, Nasar A, Suri MF, Kirmani JF, Hussein HM, Divani AA, Reddi AS. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med. 2007 Jan;25(1):32-8. — View Citation

Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. Review. — View Citation

Rodriguez-Luna D, Piñeiro S, Rubiera M, Ribo M, Coscojuela P, Pagola J, Flores A, Muchada M, Ibarra B, Meler P, Sanjuan E, Hernandez-Guillamon M, Alvarez-Sabin J, Montaner J, Molina CA. Impact of blood pressure changes and course on hematoma growth in acu — View Citation

Runzer TD, Ansley DM, Godin DV, Chambers GK. Tissue antioxidant capacity during anesthesia: propofol enhances in vivo red cell and tissue antioxidant capacity in a rat model. Anesth Analg. 2002 Jan;94(1):89-93, table of contents. — View Citation

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 i — View Citation

Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A — View Citation

van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. — View Citation

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Zheng J, Lin S, Li H, Ma J, Guo R, Fang Y, Ma L, Liu W, Liu M, You C. Perioperative antihypertensive treatment in patients of spontaneous intracerebral hemorrhage (PATICH): a clinical trial protocol. Contemp Clin Trials. 2014 Sep;39(1):9-13. doi: 10.1016/ — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality	All-cause mortality is the ratio of the total number of deaths resulting from a variety of causes over a period of time to the average population of the population over the same period.	7 days post surgery
Secondary	Acute renal failure	Increased absolute serum creatinine =0.3mg / dl (=26.5µmol / l), or =50% increase (1.5 times the baseline), or urine <0.5ml / (kg.h) for more than 6 hours Obstructive nephropathy or dehydration status)	7 days post surgery
Secondary	CK-MB release level	Clinically, CK-MB more than the total activity of CK 3 (ion exchange column chromatography) or 10 (immunosuppressive method) as the basis for the diagnosis of acute myocardial infarction.	6 hour, 12 hour,24 hour,48 hour post surgery
Secondary	Troponin T	The levels of troponin T were released before anesthesia induction at 6 hour, 12 hour, 24 hour and 48 hour	6 hour, 12 hour, 24 hour, 48 hour post surgery
Secondary	Serum creatinine	Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour	24 hour, 48 hour,72 hour post surgery