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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03933137
Other study ID # IndonesiaUAnes034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2018
Est. completion date October 18, 2018

Study information

Verified date April 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

P-POSSUM score had a predictive power of >80% to predict the length of stay of kidney transplant recipients


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date October 18, 2018
Est. primary completion date August 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects are medical record of recipients who underwent kidney transplant

Exclusion Criteria:

- Medical record was incomplete

- Patients who died during surgery or before the patient was discharged.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
P-POSSUM score's variables are divided into physiological parameters (age, cardiac, respiratory, ECG, systolic blood pressure, pulse rate, haemoglobin, leukocyte count, urea, sodium plasma, potassium plasma, and GCS) and operative parameters (operation type, number of procedures, operative blood loss, peritoneal contamination, malignancy status, CEPOD).

Locations

Country Name City State
Indonesia Rumah Sakit Cipto Mangunkusumo Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

Amer MS, Hamza SA, Wahba HMF, Barakat DB. Effects of Anemia on The Outcome in Elderly Admitted to The ICU. Indian J Med Res Pharm Sci. 2016;3(April):27-32.

Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14. — View Citation

Chen T, Wang H, Wang H, Song Y, Li X, Wang J. POSSUM and P-POSSUM as predictors of postoperative morbidity and mortality in patients undergoing hepato-biliary-pancreatic surgery: a meta-analysis. Ann Surg Oncol. 2013 Aug;20(8):2501-10. doi: 10.1245/s10434-013-2893-x. Epub 2013 Feb 23. — View Citation

Grocott MP, Levett DZ, Matejowsky C, Emberton M, Mythen MG. ASA scores in the preoperative patient: feedback to clinicians can improve data quality. J Eval Clin Pract. 2007 Apr;13(2):318-9. — View Citation

Howes TE, Cook TM, Corrigan LJ, Dalton SJ, Richards SK, Peden CJ. Postoperative morbidity survey, mortality and length of stay following emergency laparotomy. Anaesthesia. 2015 Sep;70(9):1020-7. doi: 10.1111/anae.12991. Epub 2015 Apr 15. — View Citation

Khambalia HA, Moinuddin Z, Summers AM, Tavakoli A, Pararajasingam R, Campbell T, Dhanda R, Forgacs B, Augustine T, van Dellen D. A prospective cohort study of risk prediction in simultaneous pancreas and kidney transplantation. Ann R Coll Surg Engl. 2015 Sep;97(6):445-50. doi: 10.1308/rcsann.2015.0001. Epub 2015 Aug 14. — View Citation

Li S, Zhou K, Lai Y, Shen C, Wu Y, Che G. Estimated intraoperative blood loss correlates with postoperative cardiopulmonary complications and length of stay in patients undergoing video-assisted thoracoscopic lung cancer lobectomy: a retrospective cohort study. BMC Surg. 2018 May 23;18(1):29. doi: 10.1186/s12893-018-0360-0. — View Citation

McAdams-DeMarco MA, King EA, Luo X, Haugen C, DiBrito S, Shaffer A, Kucirka LM, Desai NM, Dagher NN, Lonze BE, Montgomery RA, Walston J, Segev DL. Frailty, Length of Stay, and Mortality in Kidney Transplant Recipients: A National Registry and Prospective Cohort Study. Ann Surg. 2017 Dec;266(6):1084-1090. doi: 10.1097/SLA.0000000000002025. — View Citation

Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d. Review. — View Citation

Reyna-Sepúlveda F, Ponce-Escobedo A, Guevara-Charles A, Escobedo-Villarreal M, Pérez-Rodríguez E, Muñoz-Maldonado G, Hernández-Guedea M. Outcomes and Surgical Complications in Kidney Transplantation. Int J Organ Transplant Med. 2017;8(2):78-84. Epub 2017 May 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between each variable of P-POSSUM and length of stay Correlation between 18 variables (12 variables as physical parameters and 6 variables as operative parameters) and length of stay 1 day before surgery until discharged from hospital, up to 30 days
Primary P-POSSUM score Discrimination P-POSSUM score ability to discriminate length of stay based on variable scores: physical parameters and operative parameters 1 day before surgery until discharged from hospital, up to 30 days
Primary P-POSSUM score Calibration P-POSSUM score cutoff to predict length of stay based on variable scores: physical parameters and operative parameters 1 day before surgery until discharged from hospital, up to 30 days
Secondary Patient's length of stay post kidney transplantation Patient's length of stay post kidney transplantation From post surgery until discharged from hospital, up to 30 days
Secondary P-POSSUM score (physical parameters): Age The score for Age variable cut-off:
point for <61 years
point for 61-71 years
4 point >71 years
1 day before surgery
Secondary P-POSSUM score (physical parameters): Heart disease The score for heart disease variable cut-off:
point for no heart failure
point for diuretic, digoxin or angina/hypertension medicine usage
4 point for peripheral edema, warfarin, or borderline cardiomegaly on chest X-ray (CXR)
1 day before surgery
Secondary P-POSSUM score (physical parameters): Lung disease The score for lung disease variable cut-off:
point for no dyspnea
points for exertional dyspnea or mild COPD on CXR
4 points for limiting dyspnea or moderate COPD on CXR 8 points for dyspnea at rest or fibrosis/consolidation on CXR
1 day before surgery
Secondary P-POSSUM score (physical parameters): ECG abnormality The score for ECG abnormality variable cut-off:
1 point for normal ECG 4 points for atrial fibrillation (HR 60-90 8 points for 5 ectopic beats/min, Q waves or ST/T wave change
1 day before surgery
Secondary P-POSSUM score (physical parameters): Systolic blood pressure The score for systolic blood pressure variable cut-off:
point for 110 - 130 mmHg
points for 100-109 mmHg or 131-170 mmHg
4 points for > 170 mmHg or 90-99 mmHg 8 points for < 90 mmHg
1 day before surgery
Secondary P-POSSUM score (physical parameters): Pulse rate The score for pulse rate variable cut-off:
point for 50-80 beats per minute (bpm)
points for 40-59 bpm or 81-100 bpm
4 points for 101-120 bpm 8 points for > 121 bpm or < 40 bpm
1 day before surgery
Secondary P-POSSUM score (physical parameters): Hemoglobin The score for hemoglobin variable cut-off:
point for 13-16 g/dL
points for 11.5-12.9 or 16.1-17 d/dL
4 points for 10-11.4 or 17.1-18 g/dL 8 points for <10 or >18 g/dL
1 day before surgery
Secondary P-POSSUM score (physical parameters): Leukocyte count The score for leukocyte count variable cut-off:
point for 4.000-10.000/mm3
points for 10.100-20.000 atau 3.100-4.000/mm3
4 points for >20.000 atau <3.000/mm3
1 day before surgery
Secondary P-POSSUM score (physical parameters): Plasma potassium concentration The score for plasma potassium concentration variable cut-off:
point for 3.5-5 mmol/L
points for 3.2-3.4 or 5.1-5.3 mmol/L
4 points for 2.9-3.1 or 5.4-5.9 mmol/L 8 points for <2.9 or >5.9 mmol/L
1 day before surgery
Secondary P-POSSUM score (physical parameters): Plasma sodium concentration The score for plasma sodium concentration variable cut-off:
point for >135 mmol/L
points for 131-135 mmol/L
4 points for 126-130 mmol/L 8 points for <126 mmol/L
1 day before surgery
Secondary P-POSSUM score (operative parameters): Number of procedures The score for number of procedures variable cut-off:
1 point for one 4 points for two 8 points for more than two
1 day before surgery
Secondary P-POSSUM score (operative parameters): Intraoperative blood loss The score for intraoperative blood loss variable cut-off:
point for <100 mL
points for 101-500 mL
4 points for 501-999 mL 8 points for > 999 mL
Intraoperative
Secondary P-POSSUM score (operative parameters): Peritoneal contamination/soiling The score for peritoneal contamination/soiling variable cut-off:
point for none
points for minor (serous fluid)
4 points for local pus 8 points for free bowel content, pus or blood
Intraoperative
Secondary P-POSSUM score (operative parameters): Presence of malignancy The score for presence of malignancy variable cut-off:
point for none
points for primary only
4 points for nodal metastases 8 points for distant metastases
1 day before surgery
Secondary P-POSSUM score (operative parameters): Mode of surgery The score for mode of surgery variable cut-off:
1 point for elective 4 points for emergency resuscitation of > 2 hours possible operation < 24 hours after admission 8 points for emergency (immediate surgery < 2 hours needed)
1 day before surgery
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