Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
NCT ID: NCT02213380
Last Updated: 2024-05-09
Study Results
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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
950 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2020-01-31
Brief Summary
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The purpose of this study is evaluate postoperative delirium after general anesthesia and regional anesthesia in elderly patients undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with postoperative delirium. (3) Postoperative delirium may result in poor long-term functional outcomes.
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Detailed Description
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Postoperative delirium (POD) is an acute confusional state associated with changes in consciousness, arousal level and cognitive status. Elderly patients with hip fractures have the high incidence of delirium. The high risk factor of delirium include: Age 65 years or older, cognitive impairment/dementia, current hip fracture, severe illness and so on. Many previous studies predict that the majority of general anesthetic and sedative agents can favour postoperative delirium. However, none of studies have investigated the effect of general anesthesia and the effect of regional anesthesia and general anesthesia on the postoperative delirium in elderly patients undergoing hip fracture surgery in China. This multicentre, prospective, randomized controlled clinical trial is designed to evaluate postoperative delirium after general anesthesia and regional anesthesia in elderly patients undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with postoperative delirium. (3) Postoperative delirium may result in poor long-term functional outcomes.
This trial has the following nine investigational centers: Department of Anesthesiology, The Second Affiliated Hospital \& Yuying Children hospital of Wenzhou Medical University, Wenzhou, China; Department of Anesthesiology, Tongji Hospital, Tongji Medical college, Huazhong University of Science \& Technology, Wuhan, China; Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, China; Department of Anesthesiology, Southwest Hospital, Chongqing, China; Department of Anesthesiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China; Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Nanchang, China; Department of Anesthesiology, The Second Hospital of Anhui Medical University, Anhui, China; The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China;
Eligible patients will be assigned into two study groups (group RA: regional anesthesia will be used, group GA: General anesthesia will be used) by centre-minimization randomization (web or telephone). There are 3 stratification factors: age (65-79,≥80), presence of delirium(yes, no), dementia(yes, no). There will be two teams of investigators involved in trial procedure and the patient's follow-up. Investigator A (experienced anesthetist), who are competent in caring for patients undergoing hip fracture surgery, will perform following works, which includes informed consent, randomization, anesthesia and recovery parameters. Investigator B will visit patient the day before surgery and 7days after surgery or until discharge to assess patient for presence, type and severity of delirium, collect other data during in hospital stay and follow up patients at 6 and 12 months. Investigator B will receive uniform training of using of CAM, Delirium Rating Scale-Revised-98 (DRS-R-98), MMSE and other test used in this trial) and will be not clear about protocol.
Within 24 h before surgery, cognitive function of each patient will be assessed with the MMSE, the presence of delirium will be diagnosed with the CAM, the type and severity of delirium will be assessed with DRS-R-98 and the pain will be assessed with a 100-mm visual analog scale (VAS). Routine monitoring (NBP, continuous ECG, and pulse oximetry) was initiated on all patients. Premedication for anesthesia will be avoided before surgery. Any medication impairing cognitive function will not be recommended, if administered, must be recorded it in detail.
Investigator A will allocated the patient into group GA or group RA according the centre-randomization with a unique registration number for each eligible patient. Treatment protocols for both groups will also stipulate no sedative be administrated during operation. Routine monitoring was initiated on all patients. Hypotension (Systolic Blood Pressure\<90mmHg or drop of Mean Arterial Pressure\>30%) should be treated with vasoactive agents or fluid boluses as deemed appropriate by anesthetists.
Postoperative analgesia will be administered according to the local procedures of each clinical trial site, aiming to maintain a VAS pain score ≤ 30 mm. Both groups will receive routine postoperative care on orthopedic ward.
All randomized patients will be followed up to 7 days after surgery (or discharge from the hospital). The 7 days follow-up includes: CAM, DRS-98-R (if applicable), VAS, Analgesic use (if applicable), Sedative use (if applicable), Post-operative morbidity and laboratory results (including serum hemoglobin, hematocrit, leucocytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, serum creatinine and urea concentrations, serum sodium and potassium and serum glucose concentration). Concomitant medications, adverse events and serious adverse events are record in all study visits. Economic parameters include: time to be discharged from post operation, total cost in hospital and cost for anesthesia of patient. Investigator B will also assess patient with POD in clinic or at their residence at 6 and 12 months to assess for presence of delirium, its type and severity (CAM, DRS-98-R), cognitive function using MMSE, and quality of life using The MOS 36-item Short-Form Health Survey (SF-36) questionnaire.
The study will be monitored regularly by the clinical research associate (CRA) through visits or telephone. CRA will verify the consistency of the data recorded on the case report forms with the source documents and the management of therapeutic batches, the presence and completeness of the investigator file.
This trial has the following nine investigational centers: Department of Anesthesiology, The Second Affiliated Hospital \& Yuying Children hospital of Wenzhou Medical University, Wenzhou, China; Department of Anesthesiology, Tongji Hospital, Tongji Medical college, Huazhong University of Science \& Technology, Wuhan, China; Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, China; Department of Anesthesiology, Southwest Hospital, Chongqing, China; Department of Anesthesiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China; Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Nanchang, China; Department of Anesthesiology, The Second Hospital of Anhui Medical University, Anhui, China; The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China;
Eligible patients will be assigned into two study groups (group RA: regional anesthesia will be used, group GA: General anesthesia will be used) by centre-minimization randomization (web or telephone). There are 3 stratification factors: age (65-79,≥80), presence of delirium(yes, no), dementia(yes, no). There will be two teams of investigators involved in trial procedure and the patient's follow-up. Investigator A (experienced anesthetist), who are competent in caring for patients undergoing hip fracture surgery, will perform following works, which includes informed consent, randomization, anesthesia and recovery parameters. Investigator B will visit patient the day before surgery and 7days after surgery or until discharge to assess patient for presence, type and severity of delirium, collect other data during in hospital stay and follow up patients at 6 and 12 months. Investigator B will receive uniform training of using of CAM, Delirium Rating Scale-Revised-98 (DRS-R-98), MMSE and other test used in this trial) and will be not clear about protocol.
Within 24 h before surgery, cognitive function of each patient will be assessed with the MMSE, the presence of delirium will be diagnosed with the CAM, the type and severity of delirium will be assessed with DRS-R-98 and the pain will be assessed with a 100-mm visual analog scale (VAS). Routine monitoring (NBP, continuous ECG, and pulse oximetry) was initiated on all patients. Premedication for anesthesia will be avoided before surgery. Any medication impairing cognitive function will not be recommended, if administered, must be recorded it in detail.
Investigator A will allocated the patient into group GA or group RA according the centre-randomization with a unique registration number for each eligible patient. Treatment protocols for both groups will also stipulate no sedative be administrated during operation. Routine monitoring was initiated on all patients. Hypotension (Systolic Blood Pressure\<90mmHg or drop of Mean Arterial Pressure\>30%) should be treated with vasoactive agents or fluid boluses as deemed appropriate by anesthetists.
Postoperative analgesia will be administered according to the local procedures of each clinical trial site, aiming to maintain a VAS pain score ≤ 30 mm. Both groups will receive routine postoperative care on orthopedic ward.
All randomized patients will be followed up to 7 days after surgery (or discharge from the hospital). The 7 days follow-up includes: CAM, DRS-98-R (if applicable), VAS, Analgesic use (if applicable), Sedative use (if applicable), Post-operative morbidity and laboratory results (including serum hemoglobin, hematocrit, leucocytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, serum creatinine and urea concentrations, serum sodium and potassium and serum glucose concentration). Concomitant medications, adverse events and serious adverse events are record in all study visits. Economic parameters include: time to be discharged from post operation, total cost in hospital and cost for anesthesia of patient. Investigator B will also assess patient with POD in clinic or at their residence at 6 and 12 months to assess for presence of delirium, its type and severity (CAM, DRS-98-R), cognitive function using MMSE, and quality of life using The MOS 36-item Short-Form Health Survey (SF-36) questionnaire.
The study will be monitored regularly by the clinical research associate (CRA) through visits or telephone. CRA will verify the consistency of the data recorded on the case report forms with the source documents and the management of therapeutic batches, the presence and completeness of the investigator file.
Conditions
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Post Operative Delirium
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Data collectors or outcome assessors, e.g. the medical staff who provide post-operative care in the ward and visit patients for preoperational assessment, hospital visits and subsequent follow-ups, will be blinded from group allocation throughout the study.
Study Groups
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group GA
General anesthesia
Group Type
OTHER
method of anesthesia
Intervention Type
PROCEDURE
General anesthesia and regional anesthesia.
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
group RA
Regional anesthesia
Group Type
OTHER
method of anesthesia
Intervention Type
PROCEDURE
General anesthesia and regional anesthesia.
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Interventions
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method of anesthesia
General anesthesia and regional anesthesia.
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* older patient (≥65 years)
* patient with hip fracture and planned hip fracture surgery
* patient willing to complete this study.
* patient with hip fracture and planned hip fracture surgery
* patient willing to complete this study.
Exclusion Criteria
* patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures
* contraindication (serious illness or medical conditions) for general anesthesia
* contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio \>1.4, platelet count \<80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia;
* patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial
* patient known to susceptible to malignant hyperthermia
* known allergy or hypersensitivity to any drugs administered during this clinical trial
* previous participation in this clinical trial
* participation in another clinical trial within 4 weeks prior to selection
* contraindication (serious illness or medical conditions) for general anesthesia
* contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio \>1.4, platelet count \<80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia;
* patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial
* patient known to susceptible to malignant hyperthermia
* known allergy or hypersensitivity to any drugs administered during this clinical trial
* previous participation in this clinical trial
* participation in another clinical trial within 4 weeks prior to selection
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Research Institute for Family Planning, China
OTHER_GOV
Sponsor Role
collaborator
Wenzhou Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Ting Li
associate chief physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Fang Gao, M.D.
Role: STUDY_CHAIR
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Qingquan Lian, M.D.
Role: STUDY_CHAIR
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Jun Li, M.D.
Role: STUDY_DIRECTOR
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Ting Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Joice Yeung, M.D.
Role: STUDY_DIRECTOR
Heart of England NHS Foundation Trust
Teresa Moledy
Role: STUDY_DIRECTOR
Heart of England NHS Foundation Trust
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Site Status
Tongji Hospital, Tongji Medical college
Wuhan, Hubei, China
Site Status
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Site Status
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Site Status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
The People's Hospital of Lishi
Lishi, Zhejiang, China
Site Status
The Central Hospital of Lishui City
Lishui, Zhejiang, China
Site Status
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Site Status
Ningbo No.6 Hospital
Ningbo, Zhejiang, China
Site Status
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Site Status
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Site Status
Beijing Jishuitan Hospital
Beijing, , China
Site Status
Southwest Hospital
Chongqing, , China
Site Status
Countries
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China
References
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Sanders RD, Pandharipande PP, Davidson AJ, Ma D, Maze M. Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011 Jul 20;343:d4331. doi: 10.1136/bmj.d4331. No abstract available.
Reference Type
BACKGROUND
Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. doi: 10.1046/j.1532-5415.2001.49108.x.
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BACKGROUND
Bruce AJ, Ritchie CW, Blizard R, Lai R, Raven P. The incidence of delirium associated with orthopedic surgery: a meta-analytic review. Int Psychogeriatr. 2007 Apr;19(2):197-214. doi: 10.1017/S104161020600425X. Epub 2006 Sep 14.
Reference Type
BACKGROUND
Furlaneto ME, Garcez-Leme LE. Delirium in elderly individuals with hip fracture: causes, incidence, prevalence, and risk factors. Clinics (Sao Paulo). 2006 Feb;61(1):35-40. doi: 10.1590/s1807-59322006000100007. Epub 2006 Mar 10.
Reference Type
BACKGROUND
Nie H, Zhao B, Zhang YQ, Jiang YH, Yang YX. Pain and cognitive dysfunction are the risk factors of delirium in elderly hip fracture Chinese patients. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):e172-4. doi: 10.1016/j.archger.2011.09.012. Epub 2011 Oct 19.
Reference Type
BACKGROUND
Eeles EM, Hubbard RE, White SV, O'Mahony MS, Savva GM, Bayer AJ. Hospital use, institutionalisation and mortality associated with delirium. Age Ageing. 2010 Jul;39(4):470-5. doi: 10.1093/ageing/afq052.
Reference Type
BACKGROUND
Zakriya K, Sieber FE, Christmas C, Wenz JF Sr, Franckowiak S. Brief postoperative delirium in hip fracture patients affects functional outcome at three months. Anesth Analg. 2004 Jun;98(6):1798-1802. doi: 10.1213/01.ANE.0000117145.50236.90.
Reference Type
BACKGROUND
Kat MG, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P, Kalisvaart KJ. Long-term cognitive outcome of delirium in elderly hip surgery patients. A prospective matched controlled study over two and a half years. Dement Geriatr Cogn Disord. 2008;26(1):1-8. doi: 10.1159/000140611. Epub 2008 Jul 9.
Reference Type
BACKGROUND
Kat MG, de Jonghe JF, Vreeswijk R, van der Ploeg T, van Gool WA, Eikelenboom P, Kalisvaart KJ. Mortality associated with delirium after hip-surgery: a 2-year follow-up study. Age Ageing. 2011 May;40(3):312-8. doi: 10.1093/ageing/afr014. Epub 2011 Mar 17.
Reference Type
BACKGROUND
Fong TG, Jones RN, Shi P, Marcantonio ER, Yap L, Rudolph JL, Yang FM, Kiely DK, Inouye SK. Delirium accelerates cognitive decline in Alzheimer disease. Neurology. 2009 May 5;72(18):1570-5. doi: 10.1212/WNL.0b013e3181a4129a.
Reference Type
BACKGROUND
Witlox J, Slor CJ, Jansen RW, Kalisvaart KJ, van Stijn MF, Houdijk AP, Eikelenboom P, van Gool WA, de Jonghe JF. The neuropsychological sequelae of delirium in elderly patients with hip fracture three months after hospital discharge. Int Psychogeriatr. 2013 Sep;25(9):1521-31. doi: 10.1017/S1041610213000574. Epub 2013 May 7.
Reference Type
BACKGROUND
Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.
Reference Type
BACKGROUND
Young J, Murthy L, Westby M, Akunne A, O'Mahony R; Guideline Development Group. Diagnosis, prevention, and management of delirium: summary of NICE guidance. BMJ. 2010 Jul 28;341:c3704. doi: 10.1136/bmj.c3704. No abstract available.
Reference Type
BACKGROUND
Sanders RD. Hypothesis for the pathophysiology of delirium: role of baseline brain network connectivity and changes in inhibitory tone. Med Hypotheses. 2011 Jul;77(1):140-3. doi: 10.1016/j.mehy.2011.03.048. Epub 2011 Apr 16.
Reference Type
BACKGROUND
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
Reference Type
BACKGROUND
Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
Reference Type
BACKGROUND
Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.
Reference Type
BACKGROUND
Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.
Reference Type
BACKGROUND
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
Reference Type
BACKGROUND
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Reference Type
BACKGROUND
Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.
Reference Type
BACKGROUND
Huang MC, Lee CH, Lai YC, Kao YF, Lin HY, Chen CH. Chinese version of the Delirium Rating Scale-Revised-98: reliability and validity. Compr Psychiatry. 2009 Jan-Feb;50(1):81-5. doi: 10.1016/j.comppsych.2008.05.011. Epub 2008 Aug 23.
Reference Type
BACKGROUND
McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.
Reference Type
BACKGROUND
Li T, Li J, Yuan L, Wu J, Jiang C, Daniels J, Mehta RL, Wang M, Yeung J, Jackson T, Melody T, Jin S, Yao Y, Wu J, Chen J, Smith FG, Lian Q; RAGA Study Investigators. Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. JAMA. 2022 Jan 4;327(1):50-58. doi: 10.1001/jama.2021.22647.
Reference Type
DERIVED
Li T, Yeung J, Li J, Zhang Y, Melody T, Gao Y, Wang Y, Lian Q, Gao F; RAGA-Delirium Investigators. Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Oct 22;7(10):e016937. doi: 10.1136/bmjopen-2017-016937.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RAGA-Delirium
Identifier Type: -
Identifier Source: org_study_id
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