ProteinuriaNCT02536638
Proteinuria During Acute Pyelonephritis In Pregnancy
An observational study of Proteinuria, run by MemorialCare Health System at 1 site in United States.
Trial summary
The purpose of this research study is to compare the amount of protein excreted by the kidneys in a 24-hour period between patients who have a kidney infection and those who do not have a kidney infection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Proteinuria
- What is being tested?
- Exposure to pyelonephritis
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to inpatient management of acute pyelonephritis meeting the inclusion and exclusion criteria will be enrolled in the study. A 24 hour urine collection with be performed for evaluation of protein.
Who may be able to join
- Women ≥ 18 years old admitted at Miller Children and Women's Hospital Long Beach Memorial Medical Center
- Gestational age between 20 weeks and 0 days to 41 weeks and 0 days
- Singleton pregnancy
- Pyelonephritis group:
- meeting 2 out of 3 criteria:
- Fever > 100.4
Show all 9Show fewer
- Costovertebral angle tenderness
- Positive urine culture - without pyelonephritis group: without acute cystitis and pyelonephritis
- Positive culture defined as: quantitative count of ≥ 100,000 CFU/mL or single catheterized urine specimen with quantitative count of 100 CFU/mL.
Who cannot join
- Chronic hypertension
- Pre-gestational diabetes
- Autoimmune disorders
- Preexisting renal disease
- Multiple gestation
- Vaginal bleeding
- Preeclampsia
- Hospital admission > 3 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Children's and Women's Hospital at Long Beach Memorial Medical Center
Long Beach, California, 90806
About this study
Official title: Quantitating Proteinuria During Acute Pyelonephritis In Pregnancy
The purpose of this research study is to compare the amount of protein excreted by the kidneys in a 24-hour period between patients who have a kidney infection and those who do not have a kidney infection.
Read the detailed description
Preeclampsia is a pregnancy-unique disorder that is cured only with delivery of the baby, even if the pregnancy is premature. Defined by both blood pressure and proteinuria criteria, diagnosis is often obscured by renal processes like systemic lupus erythematosus or nephrotic syndrome that increase urinary protein spillage. Proteinuria is defined as a total protein urinary excretion exceeding 300 mg in a 24-hour urine collection in pregnancy. This is suggested to be double the protein excretion in the non-pregnancy population at 150 mg/day. A mean 24-hour urine protein excretion of 204.3 mg (± 92.5) was found in the non-hypertensive pregnant population.
Physiological changes in pregnancy predispose patients to urinary tract infections; ureteral compression by the gravid uterus, progesterone-mediated slowing of ureteral peristalsis and decreased bladder tone, and mechanical compression of the bladder contribute to impaired clearance of bacteria from the urinary tract. Indeed, acute cystitis complicates 2-4% of all pregnancies. While it has been said that urinary tract infections increase proteinuria, it is unknown how much protein spillage should be expected in the general or the pregnant populations. Hence a patient with pyelonephritis may obscure the diagnosis of preeclampsia if she spills urinary protein from her infection.
The purpose of this study is to compare the mean of 24-hour urine protein in pregnant patients with and without acute pyelonephritis.
The importance of this study will be to determine if urine protein excretion is in fact increased in the setting of pyelonephritis. This will allow for reliable evaluation of urine protein during the work up for preeclampsia in those women also found having a kidney infection.
- Conditions
- Proteinuria
- Being tested
- Exposure to pyelonephritis
- Keywords
- urine protein, pregnancy, pyelonephritis, kidney infection
- Medical subject headings
- Proteinuria, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to pyelonephritisOther
Pyelonephritis group are patients with exposure to pyelonephritis Without pyelonephritis group are patients without pyelonephritis
| Study group | Role | What they receive |
|---|---|---|
| Pyelonephritis Group | patients with pyelonephritis Receives: Other: Exposure to pyelonephritis | |
| Without pyelonephritis Group | patients without pyelonephritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine protein
urine protein will be measured upon patient enrollment to the study (i.e. during the study enrollment hospitalization)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Chan, MD, MemorialCare Health System
- Investigators
- Kenneth Chan, MD, Principal investigator, Maternal Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536638
- Sponsor's protocol ID
- 510-15
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindheimer MD, Kanter D. Interpreting abnormal proteinuria in pregnancy: the need for a more pathophysiological approach. Obstet Gynecol. 2010 Feb;115(2 Pt 1):365-375. doi: 10.1097/AOG.0b013e3181cb9644.
PubMed 20093912Osmundson SS, Lafayette RA, Bowen RA, Roque VC, Garabedian MJ, Aziz N. Maternal proteinuria in twin compared with singleton pregnancies. Obstet Gynecol. 2014 Aug;124(2 Pt 1):332-337. doi: 10.1097/AOG.0000000000000383.
PubMed 25004349Gilstrap LC 3rd, Ramin SM. Urinary tract infections during pregnancy. Obstet Gynecol Clin North Am. 2001 Sep;28(3):581-91. doi: 10.1016/s0889-8545(05)70219-9.
PubMed 11512502Jolley JA, Wing DA. Pyelonephritis in pregnancy: an update on treatment options for optimal outcomes. Drugs. 2010 Sep 10;70(13):1643-55. doi: 10.2165/11538050-000000000-00000.
PubMed 20731473Carter JL, Tomson CR, Stevens PE, Lamb EJ. Does urinary tract infection cause proteinuria or microalbuminuria? A systematic review. Nephrol Dial Transplant. 2006 Nov;21(11):3031-7. doi: 10.1093/ndt/gfl373. Epub 2006 Jul 22. No abstract available.
PubMed 16861738Rubin RH, Shapiro ED, Andriole VT, Davis RJ, Stamm WE. Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis. 1992 Nov;15 Suppl 1:S216-27. doi: 10.1093/clind/15.supplement_1.s216.
PubMed 1477233Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.
PubMed 15714408CLARK LC, THOMPSON H, BECK EI. The excretion of creatine and creatinine during pregnancy. Am J Obstet Gynecol. 1951 Sep;62(3):576-83. doi: 10.1016/0002-9378(51)91156-8. No abstract available.
PubMed 14877920Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitating Proteinuria During Acute Pyelonephritis In Pregnancy
- ClinicalTrials.gov ID
- NCT02536638
- Acronym / sponsor ID
- 510-15
- Conditions
- Proteinuria
- Keywords
- urine protein, pregnancy, pyelonephritis, kidney infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the amount of protein excreted by the kidneys in a 24-hour period between patients who have a kidney infection and those who do not have a kidney infection.
Detailed description
Preeclampsia is a pregnancy-unique disorder that is cured only with delivery of the baby, even if the pregnancy is premature. Defined by both blood pressure and proteinuria criteria, diagnosis is often obscured by renal processes like systemic lupus erythematosus or nephrotic syndrome that increase urinary protein spillage. Proteinuria is defined as a total protein urinary excretion exceeding 300 mg in a 24-hour urine collection in pregnancy. This is suggested to be double the protein excretion in the non-pregnancy population at 150 mg/day. A mean 24-hour urine protein excretion of 204.3 mg (± 92.5) was found in the non-hypertensive pregnant population.
Physiological changes in pregnancy predispose patients to urinary tract infections; ureteral compression by the gravid uterus, progesterone-mediated slowing of ureteral peristalsis and decreased bladder tone, and mechanical compression of the bladder contribute to impaired clearance of bacteria from the urinary tract. Indeed, acute cystitis complicates 2-4% of all pregnancies. While it has been said that urinary tract infections increase proteinuria, it is unknown how much protein spillage should be expected in the general or the pregnant populations. Hence a patient with pyelonephritis may obscure the diagnosis of preeclampsia if she spills urinary protein from her infection.
The purpose of this study is to compare the mean of 24-hour urine protein in pregnant patients with and without acute pyelonephritis.
The importance of this study will be to determine if urine protein excretion is in fact increased in the setting of pyelonephritis. This will allow for reliable evaluation of urine protein during the work up for preeclampsia in those women also found having a kidney infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyelonephritis Group | – | Other: Exposure to pyelonephritispatients with pyelonephritis |
| Without pyelonephritis Group | – | –patients without pyelonephritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to inpatient management of acute pyelonephritis meeting the inclusion and exclusion criteria will be enrolled in the study. A 24 hour urine collection with be performed for evaluation of protein.
Key inclusion criteria (9 listed)
- Women ≥ 18 years old admitted at Miller Children and Women's Hospital Long Beach Memorial Medical Center
- Gestational age between 20 weeks and 0 days to 41 weeks and 0 days
- Singleton pregnancy
- Pyelonephritis group:
- Fever > 100.4
Key exclusion criteria (8 listed)
- Chronic hypertension
- Pre-gestational diabetes
- Autoimmune disorders
- Preexisting renal disease
- Multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to pyelonephritisPyelonephritis group are patients with exposure to pyelonephritis Without pyelonephritis group are patients without pyelonephritis | Other | Pyelonephritis Group |
Primary outcome
24-hour urine protein
Time frame: 7 days
urine protein will be measured upon patient enrollment to the study (i.e. during the study enrollment hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 20093912Lindheimer MD, Kanter D. Interpreting abnormal proteinuria in pregnancy: the need for a more pathophysiological approach. Obstet Gynecol. 2010 Feb;115(2 Pt 1):365-375. doi: 10.1097/AOG.0b013e3181cb9644.
- Background: PubMed 25004349Osmundson SS, Lafayette RA, Bowen RA, Roque VC, Garabedian MJ, Aziz N. Maternal proteinuria in twin compared with singleton pregnancies. Obstet Gynecol. 2014 Aug;124(2 Pt 1):332-337. doi: 10.1097/AOG.0000000000000383.
- Background: PubMed 11512502Gilstrap LC 3rd, Ramin SM. Urinary tract infections during pregnancy. Obstet Gynecol Clin North Am. 2001 Sep;28(3):581-91. doi: 10.1016/s0889-8545(05)70219-9.
- Background: PubMed 20731473Jolley JA, Wing DA. Pyelonephritis in pregnancy: an update on treatment options for optimal outcomes. Drugs. 2010 Sep 10;70(13):1643-55. doi: 10.2165/11538050-000000000-00000.
- Background: PubMed 16861738Carter JL, Tomson CR, Stevens PE, Lamb EJ. Does urinary tract infection cause proteinuria or microalbuminuria? A systematic review. Nephrol Dial Transplant. 2006 Nov;21(11):3031-7. doi: 10.1093/ndt/gfl373. Epub 2006 Jul 22. No abstract available.
- Background: PubMed 1477233Rubin RH, Shapiro ED, Andriole VT, Davis RJ, Stamm WE. Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis. 1992 Nov;15 Suppl 1:S216-27. doi: 10.1093/clind/15.supplement_1.s216.
- Background: PubMed 15714408Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.
- Background: PubMed 14877920CLARK LC, THOMPSON H, BECK EI. The excretion of creatine and creatinine during pregnancy. Am J Obstet Gynecol. 1951 Sep;62(3):576-83. doi: 10.1016/0002-9378(51)91156-8. No abstract available.
- Results publication: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Chan, MD principal investigator
Maternal Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proteinuria, run by MemorialCare Health System at 1 site in United States.
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 9 inclusion and 8 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 2 Sep 2020. 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 United States. 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?
24-hour urine protein (time frame: 7 days). 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 NCT02536638, which also lists 9 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 2 Sep 2020.