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P-POSSUM Score and Length of Stay

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

Condition or disease Intervention/treatment
Length of Stay Other: Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Between P-POSSUM Score and Length of Stay in Kidney Transplant Recipients
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : October 18, 2018
Arms and Interventions
Group/Cohort Intervention/treatment
Not prolonged length of stay
Living donor patients who had ≤ 6 days length of stay after laparoscopic nephrectomy procedure
 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).
Prolonged length of stay
Living donor patients who had > 6 days length of stay after laparoscopic nephrectomy procedure
 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).
Outcome Measures
Primary Outcome Measures :
  1. Correlation between each variable of P-POSSUM and length of stay [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    Correlation between 18 variables (12 variables as physical parameters and 6 variables as operative parameters) and length of stay

  2. P-POSSUM score Discrimination [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    P-POSSUM score ability to discriminate length of stay based on variable scores: physical parameters and operative parameters

  3. P-POSSUM score Calibration [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    P-POSSUM score cutoff to predict length of stay based on variable scores: physical parameters and operative parameters


Secondary Outcome Measures :
  1. Patient's length of stay post kidney transplantation [ Time Frame: From post surgery until discharged from hospital, up to 30 days ]
    Patient's length of stay post kidney transplantation

  2. P-POSSUM score (physical parameters): Age [ Time Frame: 1 day before surgery ]

    The score for Age variable cut-off:

    1. point for <61 years
    2. point for 61-71 years

    4 point >71 years


  3. P-POSSUM score (physical parameters): Heart disease [ Time Frame: 1 day before surgery ]

    The score for heart disease variable cut-off:

    1. point for no heart failure
    2. point for diuretic, digoxin or angina/hypertension medicine usage

    4 point for peripheral edema, warfarin, or borderline cardiomegaly on chest X-ray (CXR)


  4. P-POSSUM score (physical parameters): Lung disease [ Time Frame: 1 day before surgery ]

    The score for lung disease variable cut-off:

    1. point for no dyspnea
    2. 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


  5. P-POSSUM score (physical parameters): ECG abnormality [ Time Frame: 1 day before surgery ]

    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


  6. P-POSSUM score (physical parameters): Systolic blood pressure [ Time Frame: 1 day before surgery ]

    The score for systolic blood pressure variable cut-off:

    1. point for 110 - 130 mmHg
    2. points for 100-109 mmHg or 131-170 mmHg

    4 points for > 170 mmHg or 90-99 mmHg 8 points for < 90 mmHg


  7. P-POSSUM score (physical parameters): Pulse rate [ Time Frame: 1 day before surgery ]

    The score for pulse rate variable cut-off:

    1. point for 50-80 beats per minute (bpm)
    2. points for 40-59 bpm or 81-100 bpm

    4 points for 101-120 bpm 8 points for > 121 bpm or < 40 bpm


  8. P-POSSUM score (physical parameters): Hemoglobin [ Time Frame: 1 day before surgery ]

    The score for hemoglobin variable cut-off:

    1. point for 13-16 g/dL
    2. 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


  9. P-POSSUM score (physical parameters): Leukocyte count [ Time Frame: 1 day before surgery ]

    The score for leukocyte count variable cut-off:

    1. point for 4.000-10.000/mm3
    2. points for 10.100-20.000 atau 3.100-4.000/mm3

    4 points for >20.000 atau <3.000/mm3


  10. P-POSSUM score (physical parameters): Plasma potassium concentration [ Time Frame: 1 day before surgery ]

    The score for plasma potassium concentration variable cut-off:

    1. point for 3.5-5 mmol/L
    2. 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


  11. P-POSSUM score (physical parameters): Plasma sodium concentration [ Time Frame: 1 day before surgery ]

    The score for plasma sodium concentration variable cut-off:

    1. point for >135 mmol/L
    2. points for 131-135 mmol/L

    4 points for 126-130 mmol/L 8 points for <126 mmol/L


  12. P-POSSUM score (operative parameters): Number of procedures [ Time Frame: 1 day before surgery ]

    The score for number of procedures variable cut-off:

    1 point for one 4 points for two 8 points for more than two


  13. P-POSSUM score (operative parameters): Intraoperative blood loss [ Time Frame: Intraoperative ]

    The score for intraoperative blood loss variable cut-off:

    1. point for <100 mL
    2. points for 101-500 mL

    4 points for 501-999 mL 8 points for > 999 mL


  14. P-POSSUM score (operative parameters): Peritoneal contamination/soiling [ Time Frame: Intraoperative ]

    The score for peritoneal contamination/soiling variable cut-off:

    1. point for none
    2. points for minor (serous fluid)

    4 points for local pus 8 points for free bowel content, pus or blood


  15. P-POSSUM score (operative parameters): Presence of malignancy [ Time Frame: 1 day before surgery ]

    The score for presence of malignancy variable cut-off:

    1. point for none
    2. points for primary only

    4 points for nodal metastases 8 points for distant metastases


  16. P-POSSUM score (operative parameters): Mode of surgery [ Time Frame: 1 day before 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)



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical record of recipients who undewernt kidney transplant during a period between January 2015 and December 2017
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
Indonesia
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Layout table for investigator information
Study Chair: Dita Aditianingsih, M.D, PhD Department of Anesteshiology and Intensive Care, Cipto Mangunkusumo Hospital, Universitas Indonesia
Tracking Information
First Submitted Date April 24, 2019
First Posted Date May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date May 15, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2019)
  • Correlation between each variable of P-POSSUM and length of stay [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    Correlation between 18 variables (12 variables as physical parameters and 6 variables as operative parameters) and length of stay
  • P-POSSUM score Discrimination [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    P-POSSUM score ability to discriminate length of stay based on variable scores: physical parameters and operative parameters
  • P-POSSUM score Calibration [ Time Frame: 1 day before surgery until discharged from hospital, up to 30 days ]
    P-POSSUM score cutoff to predict length of stay based on variable scores: physical parameters and operative parameters
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 27, 2019)
  • Patient's length of stay post kidney transplantation [ Time Frame: From post surgery until discharged from hospital, up to 30 days ]
    Patient's length of stay post kidney transplantation
  • P-POSSUM score (physical parameters): Age [ Time Frame: 1 day before surgery ]
    The score for Age variable cut-off:
    1. point for <61 years
    2. point for 61-71 years
    4 point >71 years
  • P-POSSUM score (physical parameters): Heart disease [ Time Frame: 1 day before surgery ]
    The score for heart disease variable cut-off:
    1. point for no heart failure
    2. point for diuretic, digoxin or angina/hypertension medicine usage
    4 point for peripheral edema, warfarin, or borderline cardiomegaly on chest X-ray (CXR)
  • P-POSSUM score (physical parameters): Lung disease [ Time Frame: 1 day before surgery ]
    The score for lung disease variable cut-off:
    1. point for no dyspnea
    2. 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
  • P-POSSUM score (physical parameters): ECG abnormality [ Time Frame: 1 day before surgery ]
    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
  • P-POSSUM score (physical parameters): Systolic blood pressure [ Time Frame: 1 day before surgery ]
    The score for systolic blood pressure variable cut-off:
    1. point for 110 - 130 mmHg
    2. points for 100-109 mmHg or 131-170 mmHg
    4 points for > 170 mmHg or 90-99 mmHg 8 points for < 90 mmHg
  • P-POSSUM score (physical parameters): Pulse rate [ Time Frame: 1 day before surgery ]
    The score for pulse rate variable cut-off:
    1. point for 50-80 beats per minute (bpm)
    2. points for 40-59 bpm or 81-100 bpm
    4 points for 101-120 bpm 8 points for > 121 bpm or < 40 bpm
  • P-POSSUM score (physical parameters): Hemoglobin [ Time Frame: 1 day before surgery ]
    The score for hemoglobin variable cut-off:
    1. point for 13-16 g/dL
    2. 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
  • P-POSSUM score (physical parameters): Leukocyte count [ Time Frame: 1 day before surgery ]
    The score for leukocyte count variable cut-off:
    1. point for 4.000-10.000/mm3
    2. points for 10.100-20.000 atau 3.100-4.000/mm3
    4 points for >20.000 atau <3.000/mm3
  • P-POSSUM score (physical parameters): Plasma potassium concentration [ Time Frame: 1 day before surgery ]
    The score for plasma potassium concentration variable cut-off:
    1. point for 3.5-5 mmol/L
    2. 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
  • P-POSSUM score (physical parameters): Plasma sodium concentration [ Time Frame: 1 day before surgery ]
    The score for plasma sodium concentration variable cut-off:
    1. point for >135 mmol/L
    2. points for 131-135 mmol/L
    4 points for 126-130 mmol/L 8 points for <126 mmol/L
  • P-POSSUM score (operative parameters): Number of procedures [ Time Frame: 1 day before surgery ]
    The score for number of procedures variable cut-off: 1 point for one 4 points for two 8 points for more than two
  • P-POSSUM score (operative parameters): Intraoperative blood loss [ Time Frame: Intraoperative ]
    The score for intraoperative blood loss variable cut-off:
    1. point for <100 mL
    2. points for 101-500 mL
    4 points for 501-999 mL 8 points for > 999 mL
  • P-POSSUM score (operative parameters): Peritoneal contamination/soiling [ Time Frame: Intraoperative ]
    The score for peritoneal contamination/soiling variable cut-off:
    1. point for none
    2. points for minor (serous fluid)
    4 points for local pus 8 points for free bowel content, pus or blood
  • P-POSSUM score (operative parameters): Presence of malignancy [ Time Frame: 1 day before surgery ]
    The score for presence of malignancy variable cut-off:
    1. point for none
    2. points for primary only
    4 points for nodal metastases 8 points for distant metastases
  • P-POSSUM score (operative parameters): Mode of surgery [ Time Frame: 1 day before 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title P-POSSUM Score and Length of Stay
Official Title Correlation Between P-POSSUM Score and Length of Stay in Kidney Transplant Recipients
Brief Summary P-POSSUM score had a predictive power of >80% to predict the length of stay of kidney transplant recipients
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Medical record of recipients who undewernt kidney transplant during a period between January 2015 and December 2017
Condition Length of Stay
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).
Study Groups/Cohorts
  • Not prolonged length of stay
    Living donor patients who had ≤ 6 days length of stay after laparoscopic nephrectomy procedure
    Intervention: Other: Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
  • Prolonged length of stay
    Living donor patients who had > 6 days length of stay after laparoscopic nephrectomy procedure
    Intervention: Other: Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 27, 2019) 		225
Original Actual Enrollment Same as current
Actual Study Completion Date October 18, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03933137
Other Study ID Numbers IndonesiaUAnes034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dita Aditianingsih, Indonesia University
Study Sponsor Indonesia University
Collaborators Not Provided
Investigators
Study Chair: Dita Aditianingsih, M.D, PhD Department of Anesteshiology and Intensive Care, Cipto Mangunkusumo Hospital, Universitas Indonesia
PRS Account Indonesia University
Verification Date April 2019

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