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Length of StayNCT03933137

P-POSSUM Score and Length of Stay

An observational study of Length of Stay, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Length of Stay
What is being tested?
Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
How many people
225 participants
Where
1 siteIndonesia
Study dates
15 May 2018to 18 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Subjects are medical record of recipients who underwent kidney transplant

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Correlation Between P-POSSUM Score and Length of Stay in Kidney Transplant Recipients

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

Conditions
Length of Stay
Being tested
Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
Keywords
mortality, morbidity, length of stay, kidney, transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) scoreOther

    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 in NCT03933137
Study groupRoleWhat they receive
Not prolonged length of stayLiving donor patients who had ≤ 6 days length of stay after laparoscopic nephrectomy procedure
Receives: Other: Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score
Prolonged length of stayLiving donor patients who had > 6 days length of stay after laparoscopic nephrectomy procedure
Receives: Other: Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 day before surgery until discharged from hospital, up to 30 days

  2. P-POSSUM score Discrimination

    P-POSSUM score ability to discriminate length of stay based on variable scores: physical parameters and operative parameters

    Measured: 1 day before surgery until discharged from hospital, up to 30 days

  3. P-POSSUM score Calibration

    P-POSSUM score cutoff to predict length of stay based on variable scores: physical parameters and operative parameters

    Measured: 1 day before surgery until discharged from hospital, up to 30 days

Secondary outcomes (16)

  1. Patient's length of stay post kidney transplantation

    Patient's length of stay post kidney transplantation

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

  2. P-POSSUM score (physical parameters): Age

    The score for Age variable cut-off:

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

    4 point >71 years

    Measured: 1 day before surgery

  3. P-POSSUM score (physical parameters): Heart disease

    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)

    Measured: 1 day before surgery

  4. P-POSSUM score (physical parameters): Lung disease

    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

    Measured: 1 day before surgery

  5. 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

    Measured: 1 day before surgery

  6. P-POSSUM score (physical parameters): Systolic blood pressure

    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

    Measured: 1 day before surgery

  7. P-POSSUM score (physical parameters): Pulse rate

    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

    Measured: 1 day before surgery

  8. P-POSSUM score (physical parameters): Hemoglobin

    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

    Measured: 1 day before surgery

  9. P-POSSUM score (physical parameters): Leukocyte count

    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

    Measured: 1 day before surgery

  10. P-POSSUM score (physical parameters): Plasma potassium concentration

    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

    Measured: 1 day before surgery

  11. P-POSSUM score (physical parameters): Plasma sodium concentration

    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

    Measured: 1 day before surgery

  12. 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

    Measured: 1 day before surgery

  13. P-POSSUM score (operative parameters): Intraoperative blood loss

    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

    Measured: Intraoperative

  14. P-POSSUM score (operative parameters): Peritoneal contamination/soiling

    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

    Measured: Intraoperative

  15. P-POSSUM score (operative parameters): Presence of malignancy

    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

    Measured: 1 day before surgery

  16. 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)

    Measured: 1 day before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start15 May 2018
  3. Primary completion15 Aug 2018
  4. Study completion18 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03933137
Sponsor's protocol ID
IndonesiaUAnes034
Status last verified
Apr 2019
First submitted
24 Apr 2019
Last updated
1 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28828167

  • 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.

    PubMed 25872411

  • 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.

    PubMed 27655240

  • 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.

    PubMed 26274754

  • 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.

    PubMed 17378882

  • 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.

    PubMed 23435569

  • 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.

    PubMed 24195875

  • 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.

    PubMed 24829444

  • 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.

    PubMed 29792183

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Length of Stay, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03933137, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

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