NCT03933137

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 24, 2019

Last Update Submit

April 27, 2019

Conditions

Keywords

mortalitymorbiditylength of staykidneytransplant

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (16)

  • Patient's length of stay post kidney transplantation

    From post surgery until discharged from hospital, up to 30 days

  • P-POSSUM score (physical parameters): Age

    1 day before surgery

  • P-POSSUM score (physical parameters): Heart disease

    1 day before surgery

  • P-POSSUM score (physical parameters): Lung disease

    1 day before surgery

  • P-POSSUM score (physical parameters): ECG abnormality

    1 day before surgery

  • +11 more secondary outcomes

Study Arms (2)

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

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

Interventions

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).

Not prolonged length of stayProlonged length of stay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical record of recipients who undewernt kidney transplant during a period between January 2015 and December 2017

You may qualify if:

  • Subjects are medical record of recipients who underwent kidney transplant

You may not qualify if:

  • Medical record was incomplete
  • Patients who died during surgery or before the patient was discharged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (10)

  • Reyna-Sepulveda F, Ponce-Escobedo A, Guevara-Charles A, Escobedo-Villarreal M, Perez-Rodriguez E, Munoz-Maldonado G, Hernandez-Guedea M. Outcomes and Surgical Complications in Kidney Transplantation. Int J Organ Transplant Med. 2017;8(2):78-84. Epub 2017 May 1.

    PMID: 28828167BACKGROUND
  • 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.

    PMID: 25872411BACKGROUND
  • 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.

    PMID: 27655240BACKGROUND
  • 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.

    PMID: 26274754BACKGROUND
  • 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. doi: 10.1111/j.1365-2753.2006.00736.x. No abstract available.

    PMID: 17378882BACKGROUND
  • 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.

    PMID: 23435569BACKGROUND
  • 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.

    PMID: 24195875BACKGROUND
  • 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.

    PMID: 24829444BACKGROUND
  • 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.

    PMID: 29792183BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Interventions

Morbidity

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Dita Aditianingsih, M.D, PhD

    Department of Anesteshiology and Intensive Care, Cipto Mangunkusumo Hospital, Universitas Indonesia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Anesthesiologist Consultant

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 1, 2019

Study Start

May 15, 2018

Primary Completion

August 15, 2018

Study Completion

October 18, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations