SepsisNCT01328509
Zinc and Inflammation in Sepsis
An observational study of Sepsis, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The purpose of the proposed project is to investigate measures of zinc status in relation to oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc depletion can modulate inflammatory responses, leading to increased oxidative stress and mitochondrial dysfunction. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to May 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Successive patients admitted to the Intensive Care Unit at Aberdeen Royal Infirmary who fulfil the following criteria for sepsis, given below, within a 24h time window. • .
Who may be able to join
- admitted to ICU with clinical suspicion or evidence of acute infection PLUS two or more of the following:
- Core temperature <36 degrees C or >38 degrees C
- Tachycardia; heart rate > 90 beats/min.
- Tachypnoea; respiratory rate > 20 breaths/min or mechanical ventilation
- White blood count >12 x 10 9/l or <4 x 10 9/l
- Control patients
- admitted to ICU with no clinical evidence or suspicion of infection
Who cannot join
- under 16 years old
- pregnant or lactating
- HIV positive
- receiving corticosteroids or other known immuno-modulatory drugs
- treated with statins in the last month
- have cancer
- have autoimmune disorders
- consent/assent is refused
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB41 8TK
About this study
The purpose of the proposed project is to investigate measures of zinc status in relation to oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc depletion can modulate inflammatory responses, leading to increased oxidative stress and mitochondrial dysfunction.
Sepsis is a severe infection is the leading cause of death in critically ill patients [1]. Zinc deficiency impairs overall immune function and resistance to infection [2]. In vitro exposure of monocytes to lipopolysaccharide (LPS) leads to decreased cellular zinc content [3] and zinc redistribution has been shown in human volunteers in response to LPS [4]. Zinc depletion occurs in hospitalized patients including those with infections, the elderly, alcoholics, trauma or burns [5-8], conditions which are common among critically ill patients with sepsis. In a mouse model of sepsis, zinc depletion prior to sepsis resulted in more inflammation and more severe organ injury and increased mortality [9]. In patients with sepsis, early feeding with zinc resulted in faster recovery of organ function compared with control [10]. Zinc status is likely to be compromised in the critically ill and that zinc depletion may affect inflammatory responses and recovery.
Read more
Although zinc is not an antioxidant itself, it binds to metallothionein [11] and zinc supplementation decreases oxidative stress [12]. Oxidative stress has been consistently reported in patients with sepsis [13-15]. We have recently shown that protection of mitochondrial function with antioxidants can reduce organ damage in rats [16]. Pentraxin-3 is an inflammatory marker which is regulated in part by antioxidants and plays a key role in innate immunity [17].
The consequences of zinc deficiency may relate, in part, to its effects on nuclear factor NFκB, a transcription factor crucial to the signalling networks involved in sepsis [18]. Higher NFκB activity is associated with increased mortality in patients with sepsis [19,20]. It is likely that compromised antioxidant defences and inflammation occurs as a consequence of zinc deficiency.
We propose to measure plasma zinc and metallothionein mRNA status in relation to inflammatory markers including key cytokines, pentraxin-3, markers of oxidative stress and antioxidant status in patients with sepsis.
Read the detailed description
Following ethical approval consent will be sought from either the patient, or assent from a near relative. Successive patients admitted to the Intensive Care Unit at Aberdeen Royal Infirmary who fulfil the following criteria for sepsis, given below, within a 24h time window, will be included.
- Clinical suspicion or evidence of acute infection
- SIRS defined by two or more of the following:
- Core temperature <36 degrees C or >38 degrees C
- Tachycardia; heart rate > 90 beats/min.
- Tachypnoea; respiratory rate > 20 breaths/min or mechanical ventilation
- White blood count >12 x 109/l or <4 x 109/l
In this pilot study we will recruit 20 patients with sepsis and 20 critically ill patients with no clinical suspicion of sepsis. Patients will be excluded if they are <16 years, pregnant or lactating, HIV positive, receiving corticosteroids or other known immuno-modulatory drugs (including statins), have cancer or autoimmune disorders or if consent/assent is refused.
Blood samples will be obtained on Days 1,2, 5, 10 and 14 of the ICU stay. Peripheral whole blood will be sampled from an indwelling arterial line and plasma will be separated for analysis of plasma zinc using atomic absorption spectroscopy. Plasma interleukin-6 (IL-6) and pentraxin-3 (PTX3) will be measured using enzyme immunoassay and total antioxidant capacity and lipid hydroperoxides will be measured colourimetrically [17]. Peripheral blood mononuclear cells (MNC) will be separated using single density gradient centrifugation, RNA extracted and metallothionein mRNA measured using qPCR [21]. Nuclear extracts of MNC will be prepared and nuclear factor kappa B (NFκB)activation measured using an enzyme immunoassay [17].
- Conditions
- Sepsis
- Keywords
- Zinc
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patients with sepsis | |
| Control | Patients with no clinical evidence of sepsis, but who are critically ill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma zinc concentration
Plasma zinc will be measured in patients with sepsis and non-spetic critically ill control patients.
Measured: 14 days
Secondary outcomes (6)
Interleukin-6
The relationship between IL-6 and plasma zinc
Measured: 14 days
Pentraxin-3
The relationship between PTX-3 and plasma zinc
Measured: 14 days
Plasma lipid peroxide
The relationship between LPO and plasma zinc
Measured: 14 days
Plasma total antioxidant capacity
The relationship between TAC and plasma zinc
Measured: 14 days
Metallothionein mRNA
Change in MTmRNA in mononuclear leucocytes in relation to plasma zinc and inflammatory markers
Measured: 14 days
Nuclear factor kappa B
Change in NFkB in nuclear extracts from mononuclear cells in relation to plasma zinc
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- UK Intensive Care Society
- Responsible party
- Sponsor
- Investigators
- Helen Galley, PhD, Principal investigator, University of AberdeenNigel Webster, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328509
- Sponsor's protocol ID
- 11/AL/0137
- Status last verified
- Jul 2013
- First submitted
- 31 Mar 2011
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
PubMed 12700374Rink L, Gabriel P. Zinc and the immune system. Proc Nutr Soc. 2000 Nov;59(4):541-52. doi: 10.1017/s0029665100000781.
PubMed 11115789Goode HF, Rathbone BJ, Kelleher J, Walker BE. Monocyte zinc and in vitro prostaglandin E2 and interleukin-1 beta production by cultured peripheral blood monocytes in patients with Crohn's disease. Dig Dis Sci. 1991 May;36(5):627-33. doi: 10.1007/BF01297030.
PubMed 2022165Gaetke LM, McClain CJ, Talwalkar RT, Shedlofsky SI. Effects of endotoxin on zinc metabolism in human volunteers. Am J Physiol. 1997 Jun;272(6 Pt 1):E952-6. doi: 10.1152/ajpendo.1997.272.6.E952.
PubMed 9227437Goode HF, Penn ND, Kelleher J, Walker BE. Evidence of cellular zinc depletion in hospitalized but not in healthy elderly subjects. Age Ageing. 1991 Sep;20(5):345-8. doi: 10.1093/ageing/20.5.345.
PubMed 1755390Schmuck A, Roussel AM, Arnaud J, Ducros V, Favier A, Franco A. Analyzed dietary intakes, plasma concentrations of zinc, copper, and selenium, and related antioxidant enzyme activities in hospitalized elderly women. J Am Coll Nutr. 1996 Oct;15(5):462-8. doi: 10.1080/07315724.1996.10718625.
PubMed 8892172Goode HF, Kelleher J, Walker BE. The effects of acute infection on indices of zinc status. Clin Nutr. 1991 Feb;10(1):55-9. doi: 10.1016/0261-5614(91)90082-n.
PubMed 16839895Berger MM, Cavadini C, Chiolero R, Dirren H. Copper, selenium, and zinc status and balances after major trauma. J Trauma. 1996 Jan;40(1):103-9. doi: 10.1097/00005373-199601000-00019.
PubMed 8576970Knoell DL, Julian MW, Bao S, Besecker B, Macre JE, Leikauf GD, DiSilvestro RA, Crouser ED. Zinc deficiency increases organ damage and mortality in a murine model of polymicrobial sepsis. Crit Care Med. 2009 Apr;37(4):1380-8. doi: 10.1097/CCM.0b013e31819cefe4.
PubMed 19242332Beale RJ, Sherry T, Lei K, Campbell-Stephen L, McCook J, Smith J, Venetz W, Alteheld B, Stehle P, Schneider H. Early enteral supplementation with key pharmaconutrients improves Sequential Organ Failure Assessment score in critically ill patients with sepsis: outcome of a randomized, controlled, double-blind trial. Crit Care Med. 2008 Jan;36(1):131-44. doi: 10.1097/01.CCM.0000297954.45251.A9.
PubMed 18007263Bell SG, Vallee BL. The metallothionein/thionein system: an oxidoreductive metabolic zinc link. Chembiochem. 2009 Jan 5;10(1):55-62. doi: 10.1002/cbic.200800511.
PubMed 19089881Prasad AS. Clinical, immunological, anti-inflammatory and antioxidant roles of zinc. Exp Gerontol. 2008 May;43(5):370-7. doi: 10.1016/j.exger.2007.10.013. Epub 2007 Nov 1.
PubMed 18054190Goode HF, Cowley HC, Walker BE, Howdle PD, Webster NR. Decreased antioxidant status and increased lipid peroxidation in patients with septic shock and secondary organ dysfunction. Crit Care Med. 1995 Apr;23(4):646-51. doi: 10.1097/00003246-199504000-00011.
PubMed 7712754Cowley HC, Bacon PJ, Goode HF, Webster NR, Jones JG, Menon DK. Plasma antioxidant potential in severe sepsis: a comparison of survivors and nonsurvivors. Crit Care Med. 1996 Jul;24(7):1179-83. doi: 10.1097/00003246-199607000-00019.
PubMed 8674332Galley HF, Howdle PD, Walker BE, Webster NR. The effects of intravenous antioxidants in patients with septic shock. Free Radic Biol Med. 1997;23(5):768-74. doi: 10.1016/s0891-5849(97)00059-2.
PubMed 9296454
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc and Inflammation in Sepsis
- ClinicalTrials.gov ID
- NCT01328509
- Acronym / sponsor ID
- 11/AL/0137
- Conditions
- Sepsis
- Keywords
- Zinc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- UK Intensive Care Society
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Apr 2011 (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 the proposed project is to investigate measures of zinc status in relation to oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc depletion can modulate inflammatory responses, leading to increased oxidative stress and mitochondrial dysfunction.
Sepsis is a severe infection is the leading cause of death in critically ill patients [1]. Zinc deficiency impairs overall immune function and resistance to infection [2]. In vitro exposure of monocytes to lipopolysaccharide (LPS) leads to decreased cellular zinc content [3] and zinc redistribution has been shown in human volunteers in response to LPS [4]. Zinc depletion occurs in hospitalized patients including those with infections, the elderly, alcoholics, trauma or burns [5-8], conditions which are common among critically ill patients with sepsis. In a mouse model of sepsis, zinc depletion prior to sepsis resulted in more inflammation and more severe organ injury and increased mortality [9]. In patients with sepsis, early feeding with zinc resulted in faster recovery of organ function compared with control [10]. Zinc status is likely to be compromised in the critically ill and that zinc depletion may affect inflammatory responses and recovery.
Although zinc is not an antioxidant itself, it binds to metallothionein [11] and zinc supplementation decreases oxidative stress [12]. Oxidative stress has been consistently reported in patients with sepsis [13-15]. We have recently shown that protection of mitochondrial function with antioxidants can reduce organ damage in rats [16]. Pentraxin-3 is an inflammatory marker which is regulated in part by antioxidants and plays a key role in innate immunity [17].
The consequences of zinc deficiency may relate, in part, to its effects on nuclear factor NFκB, a transcription factor crucial to the signalling networks involved in sepsis [18]. Higher NFκB activity is associated with increased mortality in patients with sepsis [19,20]. It is likely that compromised antioxidant defences and inflammation occurs as a consequence of zinc deficiency.
We propose to measure plasma zinc and metallothionein mRNA status in relation to inflammatory markers including key cytokines, pentraxin-3, markers of oxidative stress and antioxidant status in patients with sepsis.
Detailed description
Following ethical approval consent will be sought from either the patient, or assent from a near relative. Successive patients admitted to the Intensive Care Unit at Aberdeen Royal Infirmary who fulfil the following criteria for sepsis, given below, within a 24h time window, will be included.
- Clinical suspicion or evidence of acute infection
- SIRS defined by two or more of the following:
- Core temperature <36 degrees C or >38 degrees C
- Tachycardia; heart rate > 90 beats/min.
- Tachypnoea; respiratory rate > 20 breaths/min or mechanical ventilation
- White blood count >12 x 109/l or <4 x 109/l
In this pilot study we will recruit 20 patients with sepsis and 20 critically ill patients with no clinical suspicion of sepsis. Patients will be excluded if they are <16 years, pregnant or lactating, HIV positive, receiving corticosteroids or other known immuno-modulatory drugs (including statins), have cancer or autoimmune disorders or if consent/assent is refused.
Blood samples will be obtained on Days 1,2, 5, 10 and 14 of the ICU stay. Peripheral whole blood will be sampled from an indwelling arterial line and plasma will be separated for analysis of plasma zinc using atomic absorption spectroscopy. Plasma interleukin-6 (IL-6) and pentraxin-3 (PTX3) will be measured using enzyme immunoassay and total antioxidant capacity and lipid hydroperoxides will be measured colourimetrically [17]. Peripheral blood mononuclear cells (MNC) will be separated using single density gradient centrifugation, RNA extracted and metallothionein mRNA measured using qPCR [21]. Nuclear extracts of MNC will be prepared and nuclear factor kappa B (NFκB)activation measured using an enzyme immunoassay [17].
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Patients with sepsis |
| Control | – | –Patients with no clinical evidence of sepsis, but who are critically ill |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Successive patients admitted to the Intensive Care Unit at Aberdeen Royal Infirmary who fulfil the following criteria for sepsis, given below, within a 24h time window. • .
Key inclusion criteria (7 listed)
- admitted to ICU with clinical suspicion or evidence of acute infection PLUS two or more of the following:
- Control patients
- admitted to ICU with no clinical evidence or suspicion of infection
Key exclusion criteria (8 listed)
- under 16 years old
- pregnant or lactating
- HIV positive
- receiving corticosteroids or other known immuno-modulatory drugs
- treated with statins in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma zinc concentration
Time frame: 14 days
Plasma zinc will be measured in patients with sepsis and non-spetic critically ill control patients.
6 secondary outcomes
Interleukin-6
Time frame: 14 days
Pentraxin-3
Time frame: 14 days
Plasma lipid peroxide
Time frame: 14 days
Plasma total antioxidant capacity
Time frame: 14 days
Metallothionein mRNA
Time frame: 14 days
Nuclear factor kappa B
Time frame: 14 days
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 8 Jul 2013.
- Background: PubMed 12700374Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
- Background: PubMed 11115789Rink L, Gabriel P. Zinc and the immune system. Proc Nutr Soc. 2000 Nov;59(4):541-52. doi: 10.1017/s0029665100000781.
- Background: PubMed 2022165Goode HF, Rathbone BJ, Kelleher J, Walker BE. Monocyte zinc and in vitro prostaglandin E2 and interleukin-1 beta production by cultured peripheral blood monocytes in patients with Crohn's disease. Dig Dis Sci. 1991 May;36(5):627-33. doi: 10.1007/BF01297030.
- Background: PubMed 9227437Gaetke LM, McClain CJ, Talwalkar RT, Shedlofsky SI. Effects of endotoxin on zinc metabolism in human volunteers. Am J Physiol. 1997 Jun;272(6 Pt 1):E952-6. doi: 10.1152/ajpendo.1997.272.6.E952.
- Background: PubMed 1755390Goode HF, Penn ND, Kelleher J, Walker BE. Evidence of cellular zinc depletion in hospitalized but not in healthy elderly subjects. Age Ageing. 1991 Sep;20(5):345-8. doi: 10.1093/ageing/20.5.345.
- Background: PubMed 8892172Schmuck A, Roussel AM, Arnaud J, Ducros V, Favier A, Franco A. Analyzed dietary intakes, plasma concentrations of zinc, copper, and selenium, and related antioxidant enzyme activities in hospitalized elderly women. J Am Coll Nutr. 1996 Oct;15(5):462-8. doi: 10.1080/07315724.1996.10718625.
- Background: PubMed 16839895Goode HF, Kelleher J, Walker BE. The effects of acute infection on indices of zinc status. Clin Nutr. 1991 Feb;10(1):55-9. doi: 10.1016/0261-5614(91)90082-n.
- Background: PubMed 8576970Berger MM, Cavadini C, Chiolero R, Dirren H. Copper, selenium, and zinc status and balances after major trauma. J Trauma. 1996 Jan;40(1):103-9. doi: 10.1097/00005373-199601000-00019.
- Background: PubMed 19242332Knoell DL, Julian MW, Bao S, Besecker B, Macre JE, Leikauf GD, DiSilvestro RA, Crouser ED. Zinc deficiency increases organ damage and mortality in a murine model of polymicrobial sepsis. Crit Care Med. 2009 Apr;37(4):1380-8. doi: 10.1097/CCM.0b013e31819cefe4.
- Background: PubMed 18007263Beale RJ, Sherry T, Lei K, Campbell-Stephen L, McCook J, Smith J, Venetz W, Alteheld B, Stehle P, Schneider H. Early enteral supplementation with key pharmaconutrients improves Sequential Organ Failure Assessment score in critically ill patients with sepsis: outcome of a randomized, controlled, double-blind trial. Crit Care Med. 2008 Jan;36(1):131-44. doi: 10.1097/01.CCM.0000297954.45251.A9.
- Background: PubMed 19089881Bell SG, Vallee BL. The metallothionein/thionein system: an oxidoreductive metabolic zinc link. Chembiochem. 2009 Jan 5;10(1):55-62. doi: 10.1002/cbic.200800511.
- Background: PubMed 18054190Prasad AS. Clinical, immunological, anti-inflammatory and antioxidant roles of zinc. Exp Gerontol. 2008 May;43(5):370-7. doi: 10.1016/j.exger.2007.10.013. Epub 2007 Nov 1.
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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.
Helen Galley, PhD principal investigator
University of Aberdeen
Nigel Webster, PhD principal investigator
University of Aberdeen
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 Sepsis, run by University of Aberdeen at 1 site in United Kingdom.
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 7 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 8 Jul 2013. 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 Kingdom. 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?
Plasma zinc concentration (time frame: 14 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 NCT01328509, which also lists 23 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 8 Jul 2013.