Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury

A phase II safety and efficacy trial

Jimmi Hatton, Robert P. Rapp, Kenneth A. Kudsk, Rex Brown, Mark S. Luer, Julie G. Bukar, Sharon A. Chen, Craig J. Mcclain, Neil Gesundheit, Robert J. Dempsey, Byron Young

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

The purpose of this study was to determine the effect of insulin-like growth factor-I (IGF-I) on the catabolic state and clinical outcome of head- injured patients. Thirty-three patients between the ages of 18 and 59 years with isolated traumatic head injury and Glasgow Coma Scale (GCS) scores of 4 to 10 were randomized to one of two groups. All patients received standard neurosurgical intensive care plus aggressive nutritional support; the patients ill the treatment group also received intravenous therapy with continuous IGF-I (0.01 mg/kg/hour). During the 14-day dosing period, the control patients lost weight, whereas treated patients gained weight despite a significantly higher measured energy expenditure and tower caloric intake (p = 0.02). Daily glucose concentrations and nitrogen outputs were greater in control patients (p = 0.03) throughout the study period. During Week l, only treated patients achieved positive nitrogen balance. Fifteen of 17 treated and 13 of 16 control patients survived the 1st week. No deaths occurred in patients whose serum IGF4 concentrations were higher than 350 ng/ml. Dichotomized Glasgow Outcome Scale scores for patients with baseline GCS scores of 5 to 7 improved from poor to good for eight of 12 treated patients but for only three of 11 control patients (p = 0.06). Eight of 11 treated patients with serum IGF-I concentrations that were at least 350 ng/ml achieved moderate-to-good outcome scores at 6 months, compared to only one of five patients with lower concentrations (p < 0.05). These findings indicate that pharmacological concentrations of IGF-1 may improve clinical outcome and nitrogen utilization in patients with moderate-to-severe head injury.

Original languageEnglish (US)
Pages (from-to)779-786
Number of pages8
JournalJournal of Neurosurgery
Volume86
Issue number5
DOIs
StatePublished - Jan 1 1997

Fingerprint

Insulin-Like Growth Factor I
Craniocerebral Trauma
Safety
Glasgow Coma Scale
Nitrogen
Glasgow Outcome Scale
Weights and Measures
Nutritional Support
Critical Care
Energy Intake
Serum
Energy Metabolism

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury : A phase II safety and efficacy trial. / Hatton, Jimmi; Rapp, Robert P.; Kudsk, Kenneth A.; Brown, Rex; Luer, Mark S.; Bukar, Julie G.; Chen, Sharon A.; Mcclain, Craig J.; Gesundheit, Neil; Dempsey, Robert J.; Young, Byron.

In: Journal of Neurosurgery, Vol. 86, No. 5, 01.01.1997, p. 779-786.

Research output: Contribution to journalArticle

Hatton, J, Rapp, RP, Kudsk, KA, Brown, R, Luer, MS, Bukar, JG, Chen, SA, Mcclain, CJ, Gesundheit, N, Dempsey, RJ & Young, B 1997, 'Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury: A phase II safety and efficacy trial', Journal of Neurosurgery, vol. 86, no. 5, pp. 779-786. https://doi.org/10.3171/jns.1997.86.5.0779
Hatton, Jimmi ; Rapp, Robert P. ; Kudsk, Kenneth A. ; Brown, Rex ; Luer, Mark S. ; Bukar, Julie G. ; Chen, Sharon A. ; Mcclain, Craig J. ; Gesundheit, Neil ; Dempsey, Robert J. ; Young, Byron. / Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury : A phase II safety and efficacy trial. In: Journal of Neurosurgery. 1997 ; Vol. 86, No. 5. pp. 779-786.
@article{920486df9f0342998814c7dfafe59f6c,
title = "Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury: A phase II safety and efficacy trial",
abstract = "The purpose of this study was to determine the effect of insulin-like growth factor-I (IGF-I) on the catabolic state and clinical outcome of head- injured patients. Thirty-three patients between the ages of 18 and 59 years with isolated traumatic head injury and Glasgow Coma Scale (GCS) scores of 4 to 10 were randomized to one of two groups. All patients received standard neurosurgical intensive care plus aggressive nutritional support; the patients ill the treatment group also received intravenous therapy with continuous IGF-I (0.01 mg/kg/hour). During the 14-day dosing period, the control patients lost weight, whereas treated patients gained weight despite a significantly higher measured energy expenditure and tower caloric intake (p = 0.02). Daily glucose concentrations and nitrogen outputs were greater in control patients (p = 0.03) throughout the study period. During Week l, only treated patients achieved positive nitrogen balance. Fifteen of 17 treated and 13 of 16 control patients survived the 1st week. No deaths occurred in patients whose serum IGF4 concentrations were higher than 350 ng/ml. Dichotomized Glasgow Outcome Scale scores for patients with baseline GCS scores of 5 to 7 improved from poor to good for eight of 12 treated patients but for only three of 11 control patients (p = 0.06). Eight of 11 treated patients with serum IGF-I concentrations that were at least 350 ng/ml achieved moderate-to-good outcome scores at 6 months, compared to only one of five patients with lower concentrations (p < 0.05). These findings indicate that pharmacological concentrations of IGF-1 may improve clinical outcome and nitrogen utilization in patients with moderate-to-severe head injury.",
author = "Jimmi Hatton and Rapp, {Robert P.} and Kudsk, {Kenneth A.} and Rex Brown and Luer, {Mark S.} and Bukar, {Julie G.} and Chen, {Sharon A.} and Mcclain, {Craig J.} and Neil Gesundheit and Dempsey, {Robert J.} and Byron Young",
year = "1997",
month = "1",
day = "1",
doi = "10.3171/jns.1997.86.5.0779",
language = "English (US)",
volume = "86",
pages = "779--786",
journal = "Journal of Neurosurgery",
issn = "0022-3085",
publisher = "American Association of Neurological Surgeons",
number = "5",

}

TY - JOUR

T1 - Intravenous insulin-like growth factor-I (IGF-I) in moderate-to-severe head injury

T2 - A phase II safety and efficacy trial

AU - Hatton, Jimmi

AU - Rapp, Robert P.

AU - Kudsk, Kenneth A.

AU - Brown, Rex

AU - Luer, Mark S.

AU - Bukar, Julie G.

AU - Chen, Sharon A.

AU - Mcclain, Craig J.

AU - Gesundheit, Neil

AU - Dempsey, Robert J.

AU - Young, Byron

PY - 1997/1/1

Y1 - 1997/1/1

N2 - The purpose of this study was to determine the effect of insulin-like growth factor-I (IGF-I) on the catabolic state and clinical outcome of head- injured patients. Thirty-three patients between the ages of 18 and 59 years with isolated traumatic head injury and Glasgow Coma Scale (GCS) scores of 4 to 10 were randomized to one of two groups. All patients received standard neurosurgical intensive care plus aggressive nutritional support; the patients ill the treatment group also received intravenous therapy with continuous IGF-I (0.01 mg/kg/hour). During the 14-day dosing period, the control patients lost weight, whereas treated patients gained weight despite a significantly higher measured energy expenditure and tower caloric intake (p = 0.02). Daily glucose concentrations and nitrogen outputs were greater in control patients (p = 0.03) throughout the study period. During Week l, only treated patients achieved positive nitrogen balance. Fifteen of 17 treated and 13 of 16 control patients survived the 1st week. No deaths occurred in patients whose serum IGF4 concentrations were higher than 350 ng/ml. Dichotomized Glasgow Outcome Scale scores for patients with baseline GCS scores of 5 to 7 improved from poor to good for eight of 12 treated patients but for only three of 11 control patients (p = 0.06). Eight of 11 treated patients with serum IGF-I concentrations that were at least 350 ng/ml achieved moderate-to-good outcome scores at 6 months, compared to only one of five patients with lower concentrations (p < 0.05). These findings indicate that pharmacological concentrations of IGF-1 may improve clinical outcome and nitrogen utilization in patients with moderate-to-severe head injury.

AB - The purpose of this study was to determine the effect of insulin-like growth factor-I (IGF-I) on the catabolic state and clinical outcome of head- injured patients. Thirty-three patients between the ages of 18 and 59 years with isolated traumatic head injury and Glasgow Coma Scale (GCS) scores of 4 to 10 were randomized to one of two groups. All patients received standard neurosurgical intensive care plus aggressive nutritional support; the patients ill the treatment group also received intravenous therapy with continuous IGF-I (0.01 mg/kg/hour). During the 14-day dosing period, the control patients lost weight, whereas treated patients gained weight despite a significantly higher measured energy expenditure and tower caloric intake (p = 0.02). Daily glucose concentrations and nitrogen outputs were greater in control patients (p = 0.03) throughout the study period. During Week l, only treated patients achieved positive nitrogen balance. Fifteen of 17 treated and 13 of 16 control patients survived the 1st week. No deaths occurred in patients whose serum IGF4 concentrations were higher than 350 ng/ml. Dichotomized Glasgow Outcome Scale scores for patients with baseline GCS scores of 5 to 7 improved from poor to good for eight of 12 treated patients but for only three of 11 control patients (p = 0.06). Eight of 11 treated patients with serum IGF-I concentrations that were at least 350 ng/ml achieved moderate-to-good outcome scores at 6 months, compared to only one of five patients with lower concentrations (p < 0.05). These findings indicate that pharmacological concentrations of IGF-1 may improve clinical outcome and nitrogen utilization in patients with moderate-to-severe head injury.

UR - http://www.scopus.com/inward/record.url?scp=0030897458&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030897458&partnerID=8YFLogxK

U2 - 10.3171/jns.1997.86.5.0779

DO - 10.3171/jns.1997.86.5.0779

M3 - Article

VL - 86

SP - 779

EP - 786

JO - Journal of Neurosurgery

JF - Journal of Neurosurgery

SN - 0022-3085

IS - 5

ER -